Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

a study on Polycystic Ovary Syndrome

Summary

Eligibility
for females ages 18-35 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This study will assess the potential impact of Elagolix on disordered pituitary and ovarian hormones in women with Polycystic Ovary Syndrome (PCOS).

Official Title

Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

Details

This is a Phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of Elagolix in women with polycystic ovary syndrome (PCOS). PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if Elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage.

Keywords

Polycystic Ovary Syndrome Hormone Elagolix Syndrome

Eligibility

You can join if…

Open to females ages 18-35

  • Participants with clinical diagnosis of Polycystic Ovary Syndrome (PCOS)
  • Participants with a Body Mass Index (BMI) of 18.5 to 38kg/m2 at time of Screening

You CAN'T join if...

  • Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline
  • Participants with a significant medical condition that may require intervention during the course of study participation (such as anticipated major elective surgery)
  • Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease)
  • Participants with surgical history of hysterectomy, unilateral or bilateral oophorectomy, bilateral tubal ligation, bilateral tubal occlusion, or bilateral salpingectomy

Locations

  • UCSF Center for Reproductive Health /ID# 210836 accepting new patients
    San Francisco California 94158-2518 United States
  • R. Garn Mabey Jr, MD /ID# 211149 accepting new patients
    Las Vegas Nevada 89128 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT03951077
Phase
Phase 2
Study Type
Interventional
Last Updated
Contact us about this trial