Do you have endometriosis-related pain?

Learn more about this new clinical trial

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.

Call us or fill out the form below to inquire about participating.

Draper, UT Office: (385) 695-2300

Pleasant Grove, UT Office: (801) 763-5703

Lakewood, CO Office: (303) 985-9100

Principal Investigator:
Michael L. Twede, MD, FACOG
Corner Canyon OB/GYN Clinic
Draper, UT 84020

Principal Investigator:
David B. Young, DO, FACOG
Pleasant Grove, UT 84062

Principal Investigator:
Michael P. Johnson, MD, FACOG
Red Rocks OB/GYN
Lakewood, CO  80228

Endometriosis is a chronic, estrogen-dependent, inflammatory condition characterized by the presence of endometrial-like tissue outside the uterus. Endometriosis is a frequently debilitating condition that is associated with the most common symptoms being painful menses, nonmenstrual pelvic pain or pelvic pain in between menstrual cycles.

Elagolix, the study drug (approved for use by FDA), is effective in reducing symptoms associated with endometriosis. Women may wish to combine an oral hormonal contraceptive with elagolix therapy, but its impact on elagolix efficacy is unknown. ORILISSA IS APPROVED DRUG.

Criteria

To qualify, participants must be:

  • 18 to 49 years old
  • Not have or had hepatitis B or C (past or current history)
  • Can provide records for a documented diagnosis of endometriosis established by visualization (e.g., laparoscopy or laparotomy) or histology prior to entry
  • Not be breastfeeding, be pregnant, or planning a pregnancy until completion of study participation
  • Be ≥ 6 months post-partum, post-abortion, post-pregnancy, and post-lactation at the time of entry into the screening period

  • If ≥ 39 years of age at entry into screening must have a normal mammogram (BI-RADS classification 1 to 3 or equivalent) during screening or within 3 months prior to start of screening
  • Must have menstrual cycle lengths of 21 to 35 days for 3 consecutive months prior to screening
  • Have no history or current condition/diagnosis of major psychiatric disorders, major depression or post-traumatic stress disorder episodes, not had any suicide attempts
  • Have been nonresponsive to GnRH agonists, GnRH antagonists, depo-medroxyprogesterone acetate (DMPA), or aromatase
  • Have undiagnosed abnormal uterine, vaginal, or genital bleeding.
  • Have no drug and/or alcohol abuse within 12 months prior to screen
  • Have any cancer (including liver cancer, breast cancer, or other hormone-sensitive cancer)
  • Have Osteoporosis or other metabolic bone disease

Additional study requirements apply; contact one of the clinics for a confidential study screening.

About PRO

Physicians’ Research Options (PRO) is an experienced Clinical Research Company dedicated to the performance of Phase II, III and IV Pharmaceutical and Pilot/Pivotal Medical Device clinical trials. Our staff experience totals over 60 years in Clinical / Medical Research.

Our staff recruits for and manages studies in Utah, Nevada, and Colorado.