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

• Status: Completed
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 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, hyperprolactinemia, clinically significant infection or injury).