Phase 2
Completed N=118
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Source: ClinicalTrials.gov NCT03951077 ↗Enrolled (actual)
118
Serious AEs
0.9%
Results posted
Jun 2022
Primary outcomePrimary: Percentage of Menstrual Cycle Responders — 7.7; 0; 0; 0 percentage of participants — p=0.300
Summary
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
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 |
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).
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. Informational only — not medical advice.