NCT03951077

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

Detailed description

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 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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Elagolix	Capsule administered orally
DRUG	Placebo	Capsule administered orally

Timeline

• Start date: 2019-08-12
• Primary completion: 2021-02-10
• Completion: 2021-02-10
• First posted: 2019-05-15
• Last updated: 2022-06-08
• Results posted: 2022-06-08

Locations

54 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study