Clinical trial · Interventional
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
NCT03951077CI-TRIAL-00058964completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elagolix | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo taken orally twice a day (BID)
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Elagolix 25 mg BID
- description
- Elagolix 25 mg taken orally BID plus placebo
- interventionNames
- Drug: Elagolix
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Elagolix 50 mg Once Daily (QD)
- description
- Elagolix 50 mg taken orally QD plus placebo
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDSnabes MC, Ng J, Li H, Ali I, Shebley M, Schlaff WD. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome. F S Rep. 2023 Feb 21;4(2):206-212. doi: 10.1016/j.xfre.2023.02.007. eCollection 2023 Jun. PMID 37398623