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1 Study Matches

A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Combined Oral Contraceptives in Premenopausal Women with Documented Endometriosis and Associated Moderate to Severe Pain

18 month trial of elagolix and combined oral contraceptives for women with moderate to severe endometriosis related pain

Subjects will have a screening period of approximately 45 days. If eligible, there will be a 3 month double blind placebo controlled treatment period followed by an open label period of 15 months where all subjects will receive the study medication. Total treatment period is 18 months followed by a one month follow up.Onsite visits are once a month during screening and up until Month 3 when onsite visits will be every 3 months through Month 18.Tests include blood draws at each onsite visit, one ultrasound, an EKG, and 4 DXA scans.



Stephanie Estes
Barbara Scheetz - at or 717-531-4483
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
premenopausal females aged 18-49
diagnosed with endometriosis with moderate to severe pain
regular menstrual cycles
willing to use non hormonal contraception throughout the study

Exclusion Criteria:
currently pregnant, breastfeeding or planning a pregnancy in the next 18 months
osteoperosis or other chronic bone disease
other active chronic pain not related to endometriosis
history of hysterectomy or removal of both ovaries
current or former nicotine user if over age 33
Women's Health
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Location Contacts
Hershey, PA ,