Phase 2 N=118 Randomized Triple-blind Treatment

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

Polycystic Ovary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03951077 ↗

Enrolled (actual)

118

Serious AEs

0.9%

Results posted

Jun 2022

Primary outcome: Primary: Percentage of Menstrual Cycle Responders — 7.7; 0; 0; 0 percentage of participants — p=0.300

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Elagolix (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: AbbVie
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Menstrual Cycle Responders	7.7; 0; 0; 0; 0; 5.6	0.300
SECONDARY Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1	-1.82; -7.75; -10.65; -17.92; -7.97; -13.54	0.087

Summary

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

Eligibility Criteria

Inclusion Criteria

Participants with clinical diagnosis of PCOS.
Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03951077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.