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Medical Management of Endometriosi (1).pptx
Explore the latest clinical approaches and evidence-based protocols in the medical management of endometriosis with Dr. Laxmi Shrikhande, a leading expert in women’s reproductive health. This SlideShare presentation covers diagnostic challenges, hormonal and non-hormonal therapies, treatment goals, and patient-centric strategies to improve quality of life. Ideal for gynecologists, medical students, and healthcare professionals seeking a clear understanding of how to manage endometriosis medically.
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Medical Management of Endometriosi (1).pptx
- 1. Chairperson IndianCollege of OB/GY 2022--2023 National Corresponding Editor-Journal of OB/GY of India JOGI since last 8 years National Corresponding Secretary- Association of Medical Women, India Member-SAFOG Education Committee Vice President Elect ISOPARB 2016-17 Joint Secretary-Indian Menopause Society 2024 President –ISOPARB Vidarbha Chapter 2019-21 Chairperson-IMS Education Committee 2021-23 Chairperson-fertility enhancement Committee- ISOPARB 2023-24 President-Association of Medical Women, Nagpur AMWN 2021-24 President Menopause Society, Nagpur 2016-18 Senior Vice President FOGSI 2012 President Nagpur OB/GY Society 2005-06 Dr. Laxmi Shrikhande MBBS; MD(OB/GY); FICOG; FICMU; FICMCH; FIMS Medical Director & Senior Consultant - Shrikhande Hospital & Research Centre Pvt Ltd, Nagpur, Maharashtra FRCOG –Fellow Hon. Causa by Royal College of OB/GY, UK Nagpur Ratan Award at the hands of Union Minister Shri Nitinji Gadkari Received Bharat excellence Award for women’s health Best Committee Award as Chairperson HIV/AIDS Committee, FOGSI 2007-2009 Received appreciation letter from Maharashtra Government for her work in the field of SAVE THE GIRL CHILD • Delivered 32 orations and 550 guest lectures • Publications- 62 National & 31 International • Sensitized 2 lakh boys and girls on adolescent health issues Awards Positions
- 2. Medical Management of Endometriosis DrLaxmi Shrikhande Senior Consultant –Shrikhande Fertility Clinic , Nagpur
- 3. Endometriosis Presence ofendometrial tissue (both glands & stroma) outside the uterus. • Tissue is morphologically and functionally similar to endometrial tissue • Responds to hormones in cyclical manners Management of women with endometriosis: ESHRE 2013 Alimi Y et.al.The Clinical Anatomy of Endometriosis: A Review. Cureus. 2018 Sep 25;10(9):e3361 Characterized by chronic pelvic pain and infertility • Affects 45% - 82% of women with chronic pelvic pain • As high as 35% in women suffering from subfertility
- 4. Endometriosis Disease Burden oAffects 10%-15% of reproductive-age women o Asian women were reported to have a higher prevalence of endometriosis than Caucasians o Nearly 1/3 women have moderate-severe endometriosis Various studies conducted in Indian population have shown the incidence of endometriosis to range from 34% to 48% as diagnosed by laparoscopy Kristjansdottir et.al. Acta Obstet Gynecol Scand. 2023;102:1329–1337. Am J Reprod Immunol. 2023 Feb 1; 89(2): e13590.; Key practice points by FOGSI. 2019: https://www.fogsi.org/wp-content/uploads/tog/KPP_Key_Practice_Points_on_Endometriosis_Final.pdf
- 5. Etiopathogenesis of Endometriosis Int.J. Mol. Sci. 2023, 24(8), 7503; https://doi.org/10.3390/ijms24087503 Due to Retrograde menstruation endometrial tissue gets implanted in peritoneal cavity Originates from the metaplasia of specialised cells present in the mesothelial lining Bone marrow-derived stem cells (BMDSCs) travel to the uterine cavity and regenerate eutopic endometrium Altered Endometrial Basalis Cells invades the uterine myometrium causing lesions Shedded cells enter the uterine vasculature or lymphatic system
- 6. Clinical Manifestation o Endometriosisdevelop in various site; Peritoneal superficial lesions Ovarian cysts known as endometriomas Deep endometriosis Extrapelvic lesions o Symptoms are multiple and diverse, depending on the location of the lesions o Almost 1 in every 4 Indian women with endometriosis experiences dyspareunia Dyspareunia Chronic pelvic pain Dysmenorrhea Cyclical intestinal complaints Infertility Endometriosis is a complex disorder affecting both physiological and psychological well-being of women J Obstet Gynecol India 74, 479–483 (2024). Biomedicines 2024, 12(7), 1476; https://doi.org/10.3390/biomedicines12071476
- 7. Revised American Societyfor Reproductive Medicine (rASRM) scoring system The revised American Society for Reproductive Medicine (rASRM) scoring system is a widely recognized and utilized classification system for endometriosis. It was first introduced in 1979 by the American Fertility Society (AFS) and later revised in 1985 (rAFS score) before being renamed the rASRM score in 1996. This system is used to classify the severity of endometriosis based on intraoperative findings observed during laparoscopy or laparotomy.
- 8. (rASRM) scoring system-Components and staging The rASRM system assigns scores to different aspects of the disease, including: Peritoneal endometriosis: Scores are given based on the size of the lesions. Ovarian endometriosis: Scores are given based on the size of the lesions, including ovarian endometriomas (chocolate cysts). Posterior cul-de-sac obliteration: Points are assigned for partial or complete obliteration. Adhesions: Points are assigned for adhesions involving the ovaries and Fallopian tubes.
- 9. The total scoredetermines the stage of endometriosis. The rASRM system uses these stages: Stage I (Minimal): 1-5 points. Stage II (Mild): 6-15 points. Stage III (Moderate): 16-40 points. Stage IV (Severe): >40 points.
- 10. Advantages of (rASRM)scoring system Widely recognized: The rASRM classification is the most widely used and accepted system for describing the extent of endometriosis. Easy to understand: The system is relatively easy for healthcare providers to apply and for patients to understand.
- 11. Limitations of (rASRM)scoring system Poor correlation with symptoms: The extent of the disease as described by the rASRM score has a poor correlation with pain symptoms or infertility. Limited description of deep infiltrating endometriosis (DIE): The rASRM score does not adequately describe deep infiltrating endometriosis (DIE) and retroperitoneal structures involved in the disease. Poor reproducibility: The reproducibility of the rASRM score can be limited, especially when the disease involves the ovaries and the posterior cul-de-sac. Arbitrary scoring: The system is based on arbitrary score allocation and has wide score ranges, which may lead to subjective interpretation.
- 12. Staging of Endometriosis •Staging of endometriosis is done by the Revised American Society for Reproductive Medicine (rASRM) scoring system • It is done based on the appearance, location, type, and depth of invasion of the lesion. FOGSI 2024, Good Clinical Practice Recommendations. Updates in Endometriosis Management
- 13. Complementary systems Other classificationshave been developed to complement the rASRM system: Enzian classification: This system describes deep infiltrating endometriosis (DIE) and retroperitoneal structures in detail, including the rectovaginal septum, uterosacral ligaments, and sigmoid colon/rectum. Endometriosis Fertility Index (EFI): This system focuses on predicting fertility outcomes after surgical intervention for endometriosis, considering factors like age, duration of infertility, prior pregnancies, and tubo-ovarian function. Note: The World Endometriosis Society (WES) recommends using the rASRM classification for all women undergoing surgery for endometriosis and adding the Enzian classification for those with DIE. The EFI should be used in women where fertility is a major concern.
- 14. Enzian classification The#Enzian classification is a system used to describe and categorize endometriosis, focusing on the location and extent of the disease, including peritoneal, ovarian, and deep infiltrating endometriosis, as well as adhesions. It aims to provide a comprehensive, unified language for describing endometriosis that can be used in both surgical and imaging contexts.
- 15. Key features ofthe #Enzian classification: Endometriosis is categorized into different compartments, including: Peritoneal endometriosis (P): Superficial peritoneal implants are classified based on size (P1, P2, P3). Ovarian endometriosis (O): Endometriomas and infiltrating ovarian surface foci are categorized based on size (O1, O2, O3). Tubo-ovarian adhesions (T): Adhesions between the ovary and pelvic sidewall, uterus, or uterosacral ligaments are classified (T1, T2, T3). Deep endometriosis (A, B, C, F): Involves infiltration of organs like the bladder (A), bowel (B), rectum (C), and ureters (F). Additional compartments: Uterosacral ligaments (USL) are also considered.
- 16. Enzian classification Eachcompartment is further categorized by the extent of endometriosis (1, 2, or 3), indicating the severity of involvement. Surgical and Imaging Applicability: The classification is designed to be used both during surgery and in preoperative imaging (ultrasound, MRI). Unified Language: It provides a common language for clinicians (radiologists, surgeons, etc.) to describe endometriosis, facilitating communication and treatment planning.
- 17. Comparison with otherclassifications: The #Enzian classification is intended to be a more comprehensive system than the rASRM classification, particularly in describing deep infiltrating endometriosis. It aims to address the limitations of the rASRM classification by including a broader range of endometriosis types and locations. In essence, the #Enzian classification provides a detailed, standardized way to describe endometriosis, taking into account its various forms and locations, and is intended to be a valuable tool for both surgical planning and pre-operative imaging assessment.
- 18. Endometriosis Fertility Index(EFI) The Endometriosis Fertility Index (EFI) is a scoring system designed to predict the likelihood of natural conception after surgery for endometriosis. It's a 10-point system that considers factors like age, duration of infertility, prior pregnancy, and the "least-function score" of the fallopian tubes, fimbriae, and ovaries. The EFI is intended to be used at the end of surgery and helps clinicians assess the potential for future natural pregnancy.
- 19. What the EFIconsiders: Patient characteristics: Age, duration of infertility, and prior pregnancy history. Surgical findings: Visual assessment of the fallopian tubes, fimbriae, and ovaries, including the "least-function score" which estimates the functionality of these structures. r-ASRM (revised American Society for Reproductive Medicine) score: While the EFI includes components of the r-ASRM, it's not solely based on it.
- 20. How the EFIis used: The EFI is applied after surgery to assess the potential for natural conception. It provides a numerical score (0-10) that indicates the likelihood of pregnancy. A higher score suggests a greater chance of natural conception. The EFI can also help guide treatment decisions, such as whether to pursue assisted reproductive technologies (ART) like IVF.
- 21. Key points aboutthe EFI: It was developed by Adamson and Pasta in 2010. It's a valuable tool for predicting pregnancy outcomes after endometriosis surgery. While it considers endometriosis, the name "Endometriosis Fertility Index" may be slightly misleading as endometriosis contributes a maximum of two points to the overall score. The EFI is not designed to predict IVF outcomes.
- 22. Diagnosis History and PhysicalSymptoms • Clinical history • Cyclical and noncyclical signs and symptoms • Menstrual cycle history - AUB Pelvic Exam : • Women suspected of endometriosis should have a thorough vaginal examination • Posterior fornix palpation Imaging Tests • Transvaginal sonography, 3D –USG, MRI • Pelvic ultrasonography, computed tomography (CT) scanning, and magnetic resonance imaging (MRI) are only useful in the case of advanced disease Laparoscopy • Recommended in patients with negative imaging results and/or where empirical treatment (NSAID) was unsuccessful or inappropriate. FOGSI 2024, Good Clinical Practice Recommendations. Updates in Endometriosis Management
- 23. Treatment Goal To createan acyclic, hypoestrogenic environment either by: By locally inhibiting estrogenic stimulation (Progestins, Combined Oral Contraceptives) or Blocking ovarian estrogen secretion (GnRH-agonists or GnRH-antagonists) Limitation of current therapy include : Risk of recurrence Side effects Cost and Contraceptive effect in women desiring pregnancy FOGSI 2024, Good Clinical Practice Recommendations. Updates in Endometriosis Management
- 24. Treatment Algorithm ofEndometriosis - FOGSI FOGSI 2024, Good Clinical Practice Recommendations. Updates in Endometriosis Management
- 25. Medical Management ofEndometriosis FOGSI 2024, Good Clinical Practice Recommendations. Updates in Endometriosis Management
- 26. GnRH Agonist VsAntagonist Initial Flare Effect Severe Hypoestrogenic Effect Less Hypoestrogenic Effect Taylor HS,et.al. Clinical evaluation of the oral gonadotropin-releasing hormone-antagonist elagolix for the management of endometriosis-associated pain. Pain Manag. 2019 Sep;9(5):497-515.
- 27. Elagolix : FirstOral GnRH Antagonist
- 28. Approved Indications ofElagolix By FDA INDICATION DOSE Moderate to severe pain in endometriosis • Elagolix 150mg OD/200mg BD Heavy menstrual bleeding in uterine fibroids • Elagolix 300 mg capsule in the evening • Elagolix 300 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg capsule in the morning Innovators Prescribing Information
- 29. LH and FSHSuppression • Observed after 4 to 6 hours Estradiol Suppression • Observed within 24 hours After withdrawal of drug • Estradiol levels return to normal within 24 - 48 hours Elagolix 150mg OD Elagolix 200mg BD Elagolix • Dose - Dependent Suppression of estradiol Innovators Prescribing Information
- 30. Recommended Dosage andDuration of Use Dosing regimen Maximum Treatment Duration Coexisting Condition Initiate treatment with 150 mg once daily 24 months None Consider initiating treatment with 200 mg twice daily 6 months Dyspareunia Initiate treatment with 150 mg once daily. Use of 200 mg twice daily is not recommended. 6 months Moderate hepatic impairment (Child-Pugh Class B) Innovators Prescribing Information
- 31. GnRH agonist Vs.GnRH antagonist Elagolix has two main advantages in comparison with conventional GnRH agonists Firstly, the drug is administered orally while GnRH agonists are mostly used as long-acting depot formulations, subcutaneous implants or daily nasal solutions, which are less convenient for patients Secondly, Elagolix has a short half-life (~6 h) which allows a more rapid elimination from the system if the treatment needs to be discontinued for any reason Elagolix does not block the pituitary axis completely, and a remaining level of estrogen is able to fulfill its protective function, unlike the case of the treatment with GnRH agonists Rzewuska AM et al., Journal of Clinical Medicine. 2023; 12(3):1008. https://doi.org/10.3390/jcm12031008
- 32. Stepped care approach GnRHantagonists can be preferred in patients who: • Fail to relieve symptoms with hormonal contraceptives • Have resistance to progestins • Prefer to avoid surgery Paolo Vercelliniet.al. Elagolix for endometriosis: all that glitters is not gold, Human Reproduction, Volume 34, Issue 2, February 2019, Pages 193–199, https://doi.org/10.1093/humrep/dey368
- 33.
- 34. Taylor HS etal. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089 Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist Women 18 to 49 years ELARIS EM 1 : N=872 ELARIS EM 2: N=817 6 Months Women with surgically diagnosed endometriosis and moderate or severe endometriosis- associated pain Clinical response at 3 or 6 Months Use of analgesic dose Secondary Outcome Participants were randomly assigned in a 2:2:3 ratio to receive – 150 mg of Elagolix OD , 200 mg of Elagolix BD , or Placebo Study design: Two replicate, double-blind, randomized, 6-month phase 3 trials Primary Outcome Clinical response with respect to dysmenorrhea and non-menstrual pelvic pain at 3 months
- 35. Improvement in Dysmenorrhea& NMPP: 150mg 200mg Placebo 46.40% 75.80% 19.60% 43.40% 72.40% 22.70% EM1 EM2 % of women with clinical response to Dysmenorrhea Taylor HS et al. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089 Response at 3rd month 150mg 200mg Placebo 50.40% 54.50% 36.50% 49.80% 57.80% 36.50% EM1 EM2 % women with clinical response to NMPP Both doses showed improvement in dysmenorrhea and non-menstrual pelvic pain
- 36. Taylor HS etal. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089 Secondary Endpoint: 200mg BD dose showed • Reduction in analgesic use • Reduction in dyspareunia score
- 37. After 6 monthsof treatment, < 5% of the women in the Elagolix groups had a z score of −1.5 or less for BMD at the lumbar spine Taylor HS et al. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089 Change in Bone Mineral Density:
- 38. Conclusion Elagolix 150mg ODand 200mg BD resulted in reduction of two hallmark symptoms of endometriosis - Dysmenorrhea & Non-menstrual Pelvic Pain Sustained benefit at 6 months observed for Dysmenorrhea & Non-menstrual Pelvic Pain Elagolix 200 mg BD showed exclusive efficacy for dyspareunia at 6 months of treatment No adverse effect on endometrium observed Minimal impact on Bone Mineral Density Taylor HS et al. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089
- 39. Long-Term Outcomes ofElagolix in Women With Endometriosis – EXTENDED STUDY Aim. To evaluate the long-term efficacy and safety of Elagolix Participan ts who complete d EM 1 & EM 2 (6 Month) EM 3 Elagolix 150mg (n=149) Elagolix 200mg (n=138) EM 4 Elagolix 150mg (n=142) Elagolix 200mg (n=140) Elagolix Treatment period 12 months(6 month+ 6-month Extension study) Follow Up Period 12 months Study design: Two 6-month, phase 3, randomized, double-blind, extension studies •Primary efficacy endpoints Proportion of responders (Clinical Pain reduction and Stable or decreased rescue analgesic use) •Secondary assessments Dyspareunia, Dysmenorrhea, Pelvic pain, Use of rescue analgesic medications Surrey E et al. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160 EM - Elaris Endometriosis
- 40. Clinical Response ForDysmenorrhea And Non-menstrual Pelvic Pain Was Maintained In Extension Study Surrey E et al. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160 Proportion of Dysmenorrhea, Non-menstrual Pelvic Pain, and Dyspareunia Responders:
- 41. Mean percent changefrom baseline in dysmenorrhea Elagolix Showed Dose Response Effect For Dysmenorrhea Mean percent change from baseline in non menstrual pelvic pain Surrey E et al. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160 Proportion of Dysmenorrhea Responders:
- 42. 150mg 200mg EM 3 37.20% 58.70% 45.20% 60.00% 6Months 12 Months Axis Title % of women Clinical Response 150mg 200mg EM 4 43.50% 62.00% 45.90% 58.10% 6 Months 12 Months Axis Title % of women Clinical Response 200 mg BD dose of Elagolix showed better response to dyspareunia Surrey E et al. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160 Proportion of Dyspareunia Responders:
- 43. Reduced Analgesic Use With 150mg- Greater than 30 % mean reduction of analgesic use With 200 mg - Greater than 65 % mean reduction of analgesic use Improved QoL Significant improvement of QoL in Elagolix from baseline to months 1, 3, and 6 Reduction In Overall Endometriosis Associated Pain Significant Overall reduction of pain score in Elagolix measured by Numeric Rating Scale Surrey E et al. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160 Secondary Outcome:
- 44. Partial BMD recoverywas seen after 6 months of treatment Surrey E et al. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160 Elagolix 200mg Elagolix 150mg Placebo Effect on Bone Mineral Density:
- 45. FOGSI-ICOG recommends oralGnRH analogues including oral GnRHant - Elagolix as second line management FOGSI-ICOG Good Clinical Practice Recommendations (GCPR) Updates in Endometriosis Management,2024 ERPP- Endometriosis-related Pelvic Pain GPP- Expert/GDG consensus based DIE-Deep Infiltrating Endometriosis FOGSI-ICOG Good Clinical Practice Recommendations on Endometriosis Management, 2024
- 46. Elagolix Vs SCDepot Medroxyprogesterone Acetate for the Treatment of Endometriosis:Phase II Trial Aim. To evaluate the effects of Elagolix Vs Depot medroxyprogesterone acetate (DMPA-SC) in BMD in women with Endometriosis-associated pain Study Design. Randomized double-blind study • N =155 women in reproductive age group • Treatment Groups: • Elagolix 150 mg OD • Elagolix 75 mg BD • DMPA SC 104 mg/0.65 mL qDay 12 weeks • Duration: 24 weeks (Treatment) + 24 weeks (Post-treatment) Bruce Carr et.al.Reproductive Sciences 2014, Vol. 21(11) 1341-1351 •Primary Endpoint • Effect on BMD •Secondary Assessments • Safety and efficacy assessment Responder Rate:
- 47. Effect on estradiollevels : After discontinuation, median E2 concentrations increased starting at week 28 in the elagolix groups consistent with a return of normal menstrual cycles Median estradiol concentrations through week 48
- 48. Conclusion • Study showedDMPA-SC and Elagolix had similar impact on BMD over a 24-week period • Although both drugs showed similar effect on endometriosis associated pain, Elagolix showed additional benefits in terms of reduction in uterine bleeding and rapid return to menses • Minimal BMD changes at 24 weeks (Treatment) in all 3 groups • Improvement seen at 48 weeks (post-treatment) Bruce Carr et.al.Reproductive Sciences 2014, Vol. 21(11) 1341-1351 Mean % of days with uterine bleeding Elagolix 150 mg: 15.5% +1.0% DMPA SC: 30.4% + 2.4% Return to mensus after discontinuation: (Mean No. of days) Elagolix 150 mg: 24.2 DMPA SC: 72.1 Effect on Uterine Bleeding and return to mensus: Effect on BMD:
- 49. Controlled Ovarian Stimulation •In a prospective cohort study comparing Elagolix 200mg OD (E) vs ganirelix (G) for COS in IVF patients showed no cases of premature ovulation in both groups • Both groups showed similar fertilization rate (84.6% ganirelix vs 79.7% elagolix) and blastocyst development rate (57.3% ganirelix vs 62.9% elagolix) • Elagolix shows less Invasive and cheaper option F S Rep. 2023 Mar 25;4(2):179-182 • In another study, IVF patients were given either Elagolix 50 mg OD or ganirelix/cetrotide injection daily for ovulation suppression. • Both showed similar IVF cycle outcomes (No. of mature oocytes, the fertilization rate, and endometrial lining thickness) with Elagolix showing a convenient route of administration J Clin Endocrinol Metab. 2025 Jan 21;110(2):e456-e460. Other possible usage of Elagolix
- 50. Summary Endometriosis isan estrogen dependent condition characterized by chronic pelvic pain Elagolix, an oral GnRH receptor antagonist is used for moderate-severe pain associated with endometriosis In large clinical trial of ELARIS 1 and ELARIS II, Elagolix resulted in reduction of two hallmark symptoms Dysmenorrhea & Non-menstrual Pelvic Pain Higher doses of elagolix showed efficacy towards dyspareunia along with reduction in analgesic usage Advantages of Elagolix includes minimal flare-ups and rapid reversal of estradiol levels Newer clinical trials of Elagolix usage in IVF patients for Controlled Ovarian Stimulation is promising
- 51. My World ofsharing happiness! Shrikhande Fertility Clinic Ph- 91 8805577600 [email protected]
- 53. The Art ofLiving Anything that helps you to become unconditionally happy and loving is what is called spirituality. H. H. Sri Sri Ravishakar
Editor's Notes
- #5 Theories on Endometriosis Pathogenesis: 1. Retrograde Menstruation: This is the most widely accepted theory. It suggests that during menstruation, endometrial fragments flow backward through the fallopian tubes and implant on other pelvic organs or the peritoneum. 2. Endometrial Stem Cell Implantation: This theory expands on retrograde menstruation, proposing that endometrial stem cells and their supporting cells are shed and subsequently implant. 3. Müllerian Remnant Abnormalities: This theory focuses on the development of endometriosis in the cul-de-sac and uterosacral ligaments. It suggests that abnormalities in the Müllerian ducts during fetal development could lead to misplaced endometrial tissue. 4. Coelomic Metaplasia: This theory proposes that the coelomic epithelium (which lines the abdominal cavity) can transform into endometrial tissue. Other Factors: Immune System Dysregulation: The immune system may play a role in endometriosis, with some studies suggesting that immune cells may not effectively clear misplaced endometrial tissue or may even contribute to its growth. Hormonal Imbalances: Estrogen is known to play a role in endometrial growth, and imbalances in estrogen levels or sensitivity may contribute to the development and progression of endometriosis. Genetic and Epigenetic Factors: Genetic predisposition and epigenetic changes (modifications to gene expression) may also influence a woman's susceptibility to endometriosis. Oxidative Stress: An imbalance between the production of reactive oxygen species and the body's antioxidant defenses can cause damage to cells and potentially contribute to endometriosis development. Environmental Factors: Exposure to certain environmental toxins, like endocrine disruptors, may also play a role. In summary, endometriosis pathogenesis is likely multifactorial, with various factors interacting to create the condition. While retrograde menstruation is a prominent theory, other mechanisms, including immune dysregulation, hormonal imbalances, and genetic factors, are also believed to be involved. The exact interplay of these factors and the specific mechanisms leading to the development of endometriosis in individual women are still being investigated.
- #30 Child-Pugh class B is a liver disease classification that indicates moderately severe liver damage. It is assigned when a patient's Child-Pugh score is between 7 and 9
- #31 Dose-dependent suppression of LH and FSH levels was observed 4 to 6 hours after administration Estrogen levels return to baseline 24 to 48 hours after discontinuation
- #36 N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist Hugh S Taylor 1, Linda C Giudice 1, Bruce A Lessey 1, Mauricio S Abrao 1, Jan Kotarski 1, David F Archer 1, Michael P Diamond 1, Eric Surrey 1, Neil P Johnson 1, Nelson B Watts 1, J Chris Gallagher 1, James A Simon 1, Bruce R Carr 1, W Paul Dmowski 1, Nicholas Leyland 1, Jean P Rowan 1, W Rachel Duan 1, Juki Ng 1, Brittany Schwefel 1, James W Thomas 1, Rita I Jain 1, Kristof Chwalisz 1 Affiliations Expand PMID: 28525302 DOI: 10.1056/NEJMoa1700089 Free article Abstract Background: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. Methods: We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain. The two primary efficacy end points were the proportion of women who had a clinical response with respect to dysmenorrhea and the proportion who had a clinical response with respect to nonmenstrual pelvic pain at 3 months. Each of these end points was measured as a clinically meaningful reduction in the pain score and a decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary. Results: A total of 872 women underwent randomization in Elaris EM-I and 817 in Elaris EM-II; of these women, 653 (74.9%) and 632 (77.4%), respectively, completed the intervention. At 3 months, a significantly greater proportion of women who received each elagolix dose met the clinical response criteria for the two primary end points than did those who received placebo. In Elaris EM-I, the percentage of women who had a clinical response with respect to dysmenorrhea was 46.4% in the lower-dose elagolix group and 75.8% in the higher-dose elagolix group, as compared with 19.6% in the placebo group; in Elaris EM-II, the corresponding percentages were 43.4% and 72.4%, as compared with 22.7% (P<0.001 for all comparisons). In Elaris EM-I, the percentage of women who had a clinical response with respect to nonmenstrual pelvic pain was 50.4% in the lower-dose elagolix group and 54.5% in the higher-dose elagolix group, as compared with 36.5% in the placebo group (P<0.001 for all comparisons); in Elaris EM-II, the corresponding percentages were 49.8% and 57.8%, as compared with 36.5% (P=0.003 and P<0.001, respectively). The responses with respect to dysmenorrhea and nonmenstrual pelvic pain were sustained at 6 months. Women who received elagolix had higher rates of hot flushes (mostly mild or moderate), higher levels of serum lipids, and greater decreases from baseline in bone mineral density than did those who received placebo; there were no adverse endometrial findings. Conclusions: Both higher and lower doses of elagolix were effective in improving dysmenorrhea and nonmenstrual pelvic pain during a 6-month period in women with endometriosis-associated pain. The two doses of elagolix were associated with hypoestrogenic adverse effects.
- #37 N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist Hugh S Taylor 1, Linda C Giudice 1, Bruce A Lessey 1, Mauricio S Abrao 1, Jan Kotarski 1, David F Archer 1, Michael P Diamond 1, Eric Surrey 1, Neil P Johnson 1, Nelson B Watts 1, J Chris Gallagher 1, James A Simon 1, Bruce R Carr 1, W Paul Dmowski 1, Nicholas Leyland 1, Jean P Rowan 1, W Rachel Duan 1, Juki Ng 1, Brittany Schwefel 1, James W Thomas 1, Rita I Jain 1, Kristof Chwalisz 1 Affiliations Expand PMID: 28525302 DOI: 10.1056/NEJMoa1700089 Free article Abstract Background: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. Methods: We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain. The two primary efficacy end points were the proportion of women who had a clinical response with respect to dysmenorrhea and the proportion who had a clinical response with respect to nonmenstrual pelvic pain at 3 months. Each of these end points was measured as a clinically meaningful reduction in the pain score and a decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary. Results: A total of 872 women underwent randomization in Elaris EM-I and 817 in Elaris EM-II; of these women, 653 (74.9%) and 632 (77.4%), respectively, completed the intervention. At 3 months, a significantly greater proportion of women who received each elagolix dose met the clinical response criteria for the two primary end points than did those who received placebo. In Elaris EM-I, the percentage of women who had a clinical response with respect to dysmenorrhea was 46.4% in the lower-dose elagolix group and 75.8% in the higher-dose elagolix group, as compared with 19.6% in the placebo group; in Elaris EM-II, the corresponding percentages were 43.4% and 72.4%, as compared with 22.7% (P<0.001 for all comparisons). In Elaris EM-I, the percentage of women who had a clinical response with respect to nonmenstrual pelvic pain was 50.4% in the lower-dose elagolix group and 54.5% in the higher-dose elagolix group, as compared with 36.5% in the placebo group (P<0.001 for all comparisons); in Elaris EM-II, the corresponding percentages were 49.8% and 57.8%, as compared with 36.5% (P=0.003 and P<0.001, respectively). The responses with respect to dysmenorrhea and nonmenstrual pelvic pain were sustained at 6 months. Women who received elagolix had higher rates of hot flushes (mostly mild or moderate), higher levels of serum lipids, and greater decreases from baseline in bone mineral density than did those who received placebo; there were no adverse endometrial findings. Conclusions: Both higher and lower doses of elagolix were effective in improving dysmenorrhea and nonmenstrual pelvic pain during a 6-month period in women with endometriosis-associated pain. The two doses of elagolix were associated with hypoestrogenic adverse effects.
- #38 N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist Hugh S Taylor 1, Linda C Giudice 1, Bruce A Lessey 1, Mauricio S Abrao 1, Jan Kotarski 1, David F Archer 1, Michael P Diamond 1, Eric Surrey 1, Neil P Johnson 1, Nelson B Watts 1, J Chris Gallagher 1, James A Simon 1, Bruce R Carr 1, W Paul Dmowski 1, Nicholas Leyland 1, Jean P Rowan 1, W Rachel Duan 1, Juki Ng 1, Brittany Schwefel 1, James W Thomas 1, Rita I Jain 1, Kristof Chwalisz 1 Affiliations Expand PMID: 28525302 DOI: 10.1056/NEJMoa1700089 Free article Abstract Background: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. Methods: We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain. The two primary efficacy end points were the proportion of women who had a clinical response with respect to dysmenorrhea and the proportion who had a clinical response with respect to nonmenstrual pelvic pain at 3 months. Each of these end points was measured as a clinically meaningful reduction in the pain score and a decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary. Results: A total of 872 women underwent randomization in Elaris EM-I and 817 in Elaris EM-II; of these women, 653 (74.9%) and 632 (77.4%), respectively, completed the intervention. At 3 months, a significantly greater proportion of women who received each elagolix dose met the clinical response criteria for the two primary end points than did those who received placebo. In Elaris EM-I, the percentage of women who had a clinical response with respect to dysmenorrhea was 46.4% in the lower-dose elagolix group and 75.8% in the higher-dose elagolix group, as compared with 19.6% in the placebo group; in Elaris EM-II, the corresponding percentages were 43.4% and 72.4%, as compared with 22.7% (P<0.001 for all comparisons). In Elaris EM-I, the percentage of women who had a clinical response with respect to nonmenstrual pelvic pain was 50.4% in the lower-dose elagolix group and 54.5% in the higher-dose elagolix group, as compared with 36.5% in the placebo group (P<0.001 for all comparisons); in Elaris EM-II, the corresponding percentages were 49.8% and 57.8%, as compared with 36.5% (P=0.003 and P<0.001, respectively). The responses with respect to dysmenorrhea and nonmenstrual pelvic pain were sustained at 6 months. Women who received elagolix had higher rates of hot flushes (mostly mild or moderate), higher levels of serum lipids, and greater decreases from baseline in bone mineral density than did those who received placebo; there were no adverse endometrial findings. Conclusions: Both higher and lower doses of elagolix were effective in improving dysmenorrhea and nonmenstrual pelvic pain during a 6-month period in women with endometriosis-associated pain. The two doses of elagolix were associated with hypoestrogenic adverse effects.
- #39 A Z-score for bone mineral density (BMD) compares a person's bone density to the average for people of the same age, sex, and ethnicity. With decrease in z score bone risk increases +1 to -1: Your bone density is normal -1 to -2.5: Your bone density is slightly below normal, also known as osteopenia -2.5 or lower: Your bone density is in the osteoporosis range
- #41 Objective To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. Methods Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate. Results Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV 550.8%) and 78.2% at 200 mg twice daily (Elaris EMIV 575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.5% at 150 mg once daily (Elaris EM-IV 566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV 567.2%).”After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings.Conclusion Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use
- #42 Objective To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. Methods Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate. Results Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV 550.8%) and 78.2% at 200 mg twice daily (Elaris EMIV 575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.5% at 150 mg once daily (Elaris EM-IV 566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV 567.2%).”After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings.Conclusion Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use
- #43 Objective To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. Methods Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate. Results Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV 550.8%) and 78.2% at 200 mg twice daily (Elaris EMIV 575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.5% at 150 mg once daily (Elaris EM-IV 566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV 567.2%).”After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings.Conclusion Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use
- #44 After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV 45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV 58.1%)
- #45 Objective To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. Methods Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate. Results Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV 550.8%) and 78.2% at 200 mg twice daily (Elaris EMIV 575.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.5% at 150 mg once daily (Elaris EM-IV 566.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV 567.2%).”After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings.Conclusion Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use
- #46 After 6 months off treatment with elagolix BMD was partially improved
- #48 Abstract. This randomized double-blind study, with 24-week treatment and 24-week posttreatment periods, evaluated the effects of elagolix (150 mg every day, 75 mg twice a day) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) on bone mineral density (BMD), in women with endometriosis-associated pain (n ¼ 252). All treatments induced minimal mean changes from baseline in BMD at week 24 (elagolix 150 mg: 0.11%/0.47%, elagolix 75 mg: 1.29%/1.2%, and DMPA-SC: 0.99%/ 1.29% in the spine and total hip, respectively), with similar or less changes at week 48 (posttreatment). Elagolix was associated with improvements in endometriosis-associated pain, assessed with composite pelvic signs and symptoms score (CPSSS) and visual analogue scale, including statistical noninferiority to DMPA-SC in dysmenorrhea and nonmenstrual pelvic pain components of the CPSSS. The most common adverse events (AEs) in elagolix groups were headache, nausea, and nasopharyngitis, whereas the most common AEs in the DMPA-SC group were headache, nausea, upper respiratory tract infection, and mood swings. This study showed that similar to DMPA-SC, elagolix treatment had minimal impact on BMD over a 24-week period and demonstrated similar efficacy on endometriosis-associated pain.
- #49 Abstract. This randomized double-blind study, with 24-week treatment and 24-week posttreatment periods, evaluated the effects of elagolix (150 mg every day, 75 mg twice a day) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) on bone mineral density (BMD), in women with endometriosis-associated pain (n ¼ 252). All treatments induced minimal mean changes from baseline in BMD at week 24 (elagolix 150 mg: 0.11%/0.47%, elagolix 75 mg: 1.29%/1.2%, and DMPA-SC: 0.99%/ 1.29% in the spine and total hip, respectively), with similar or less changes at week 48 (posttreatment). Elagolix was associated with improvements in endometriosis-associated pain, assessed with composite pelvic signs and symptoms score (CPSSS) and visual analogue scale, including statistical noninferiority to DMPA-SC in dysmenorrhea and nonmenstrual pelvic pain components of the CPSSS. The most common adverse events (AEs) in elagolix groups were headache, nausea, and nasopharyngitis, whereas the most common AEs in the DMPA-SC group were headache, nausea, upper respiratory tract infection, and mood swings. This study showed that similar to DMPA-SC, elagolix treatment had minimal impact on BMD over a 24-week period and demonstrated similar efficacy on endometriosis-associated pain.
- #50 Abstract. This randomized double-blind study, with 24-week treatment and 24-week posttreatment periods, evaluated the effects of elagolix (150 mg every day, 75 mg twice a day) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) on bone mineral density (BMD), in women with endometriosis-associated pain (n ¼ 252). All treatments induced minimal mean changes from baseline in BMD at week 24 (elagolix 150 mg: 0.11%/0.47%, elagolix 75 mg: 1.29%/1.2%, and DMPA-SC: 0.99%/ 1.29% in the spine and total hip, respectively), with similar or less changes at week 48 (posttreatment). Elagolix was associated with improvements in endometriosis-associated pain, assessed with composite pelvic signs and symptoms score (CPSSS) and visual analogue scale, including statistical noninferiority to DMPA-SC in dysmenorrhea and nonmenstrual pelvic pain components of the CPSSS. The most common adverse events (AEs) in elagolix groups were headache, nausea, and nasopharyngitis, whereas the most common AEs in the DMPA-SC group were headache, nausea, upper respiratory tract infection, and mood swings. This study showed that similar to DMPA-SC, elagolix treatment had minimal impact on BMD over a 24-week period and demonstrated similar efficacy on endometriosis-associated pain.