Longer Breastfeeding Linked To Lower Risk of Endometriosis

MedicalResearch.com Interview with:

Leslie V. Farland, ScD Assistant Director of Epidemiologic Research Center for Infertility and Reproductive Surgery Brigham and Women's Hospital | Harvard Medical School  Instructor | Harvard T.H. Chan School of Public Health

Dr. Farland

Leslie V. Farland, ScD
Assistant Director of Epidemiologic Research
Center for Infertility and Reproductive Surgery
Brigham and Women’s Hospital | Harvard Medical School
Instructor | Harvard T.H. Chan School of Public Health

MedicalResearch.com: What is the background for this study?

Response: Endometriosis is chronic gynecologic condition that affects approximately ten percent of women. Women with endometriosis can experience painful menstrual periods, general chronic pelvic pain, and pain associated with intercourse. Currently we know very few modifiable risk factors for endometriosis.

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Phase 3 Studies Demonstrate Reduce Endometriosis-Associated Pain with Elagolix

MedicalResearch.com Interview with:

Hugh S. Taylor, M.D. Anitta O’keeffe Young Professor and Chair Departemnt of Obstetrics, Gynecology and Reproductive Sciences Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital

Dr. Taylor

Hugh S. Taylor, M.D.
Anitta O’keeffe Young Professor and Chair
Departemnt of Obstetrics, Gynecology and Reproductive Sciences
Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Elagolix is an investigational, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.

Data from two replicate Phase 3 studies evaluating the efficacy and safety of elagolix were published in the New England Journal of Medicine. Elagolix demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of elagolix was consistent across both Phase 3 trials and also consistent with prior elagolix studies.

Ultimately, the studies showed that both elagolix doses (150 mg QD and 200 mg BID) were effective in improving dysmenorrhea, non-menstrual pelvic pain and quality of life over 6 months in women with endometriosis-associated pain. The elagolix safety/tolerability profile was consistent with the mechanism of action.

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GnRH Receptor Antagonist Elagolix Offers Hope for Patients With Endometriosis

MedicalResearch.com Interview with:

Hugh S. Taylor, MD Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair of Obstetrics Gynecology, and Reproductive Sciences, Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital

Dr. Hugh S. Taylor

Hugh S. Taylor, MD
Anita O’Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair of Obstetrics
Gynecology, and Reproductive Sciences, Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The abstract presented at ASRM featured results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. Elagolix is an investigational, orally administered, gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone and follicle-stimulating hormone secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.

The data demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea) and non-menstrual pelvic pain associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of Elagolix was consistent across both Phase 3 trials and also consistent with prior Elagolix studies.

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Does Seminal Fluid Increase Risk of Endometriosis

MedicalResearch.com Interview with:
Dr Jonathan McGuane PhD.
Robinson Research Institute and Discipline of Obstetrics and Gynaecology
School of Paediatrics and Reproductive Health
University of Adelaide, Adelaide, South Australia, Australia

Medical Research: What is the background for this study?

Dr. McGuane: Epidemiological studies suggest that endometriosis is present more often in women who report having intercourse during menstruation compared to those who don’t (Filer and Wu, J Reprod Med 1989:887-890). The idea for this study came from our research showing that seminal plasma induces marked changes in the immunology of the female reproductive tract, which are essential for optimal implantation of an embryo and subsequent fetal development. However, some of these immunological changes could increase the likelihood of endometrial tissue developing into an endometriotic lesion if it subsequently ends up in the peritoneum via retrograde menstruation (a la Sampson’s hypothesis). This could help to explain the epidemiological findings cited above. Our study was designed to explore “proof-of-principle” of this concept by exposing human endometrial tissue directly to seminal plasma or control medium in vitro, and transplanting it under the skin of receptive mice.

Medical Research: What are the main findings?

Dr. McGuane: After two weeks, endometrial tissue exposed to seminal plasma was significantly larger than control tissue. This appeared to be the result of increased cell proliferation and tissue survival. Although we hypothesised that an immune-mediated mechanism would underlie the changes induced by seminal plasma, we did not find much evidence to support this idea; however, more work needs to be done on this aspect of the research.

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