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

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
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Elagolix Drug: Placebo Phase 2

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Elagolix

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo taken orally twice a day (BID)
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Locations
Show Show 54 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] October 2, 2020
Statistical Analysis Plan  [PDF] October 28, 2019

Additional Information:
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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/

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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
Keywords provided by AbbVie:
Polycystic Ovary Syndrome
Hormone
Elagolix
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases