Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03951077 |
Recruitment Status :
Completed
First Posted : May 15, 2019
Results First Posted : June 8, 2022
Last Update Posted : June 8, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Drug: Elagolix Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome |
Actual Study Start Date : | August 12, 2019 |
Actual Primary Completion Date : | February 10, 2021 |
Actual Study Completion Date : | February 10, 2021 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo taken orally twice a day (BID)
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Drug: Placebo
Capsule administered orally |
Experimental: Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
|
Drug: Elagolix
Capsule administered orally
Other Name: Orilissa Drug: Placebo Capsule administered orally |
Experimental: Elagolix 50 mg Once Daily (QD)
Elagolix 50 mg taken orally QD plus placebo
|
Drug: Elagolix
Capsule administered orally
Other Name: Orilissa Drug: Placebo Capsule administered orally |
Experimental: Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
|
Drug: Elagolix
Capsule administered orally
Other Name: Orilissa Drug: Placebo Capsule administered orally |
Experimental: Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
|
Drug: Elagolix
Capsule administered orally
Other Name: Orilissa Drug: Placebo Capsule administered orally |
Experimental: Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
|
Drug: Elagolix
Capsule administered orally
Other Name: Orilissa Drug: Placebo Capsule administered orally |
- Percentage of Menstrual Cycle Responders [ Time Frame: Week 0 (Baseline) to Week 24 (Month 6) ]A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
- Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1 [ Time Frame: Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951077

Study Director: | ABBVIE INC. | AbbVie |
Documents provided by AbbVie:
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT03951077 |
Other Study ID Numbers: |
M16-837 |
First Posted: | May 15, 2019 Key Record Dates |
Results First Posted: | June 8, 2022 |
Last Update Posted: | June 8, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | For details on when studies are available for sharing, please refer to the link below. |
Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link. |
URL: | https://vivli.org/ourmember/abbvie/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Polycystic Ovary Syndrome Hormone Elagolix |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |