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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03951077
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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 polycystic ovary syndrome (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.
Study Design
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Study Type : Interventional
Estimated Enrollment : 130 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
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : February 14, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Various doses of Elagolix plus matching placebo
Various dosing regimens for Elagolix taken orally plus matching placebo taken orally depending on arm assignment.
 Drug: Elagolix
Capsule administered orally
Other Name: Orilissa

Drug: Placebo
Capsule administered orally
Placebo Comparator: Placebo
Placebo taken orally twice a day (BID)
 Drug: Placebo
Capsule administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Menstrual Cycle Responders [ Time Frame: Week 0 (Baseline) to Week 24 ]
    Menstrual cycle improvement will be assessed by the participant's e-diary.


Secondary Outcome Measures :
  1. Change in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) [ Time Frame: Week 0 (Baseline) to Week 1 ]
    Demonstrates the effects of the drug on the rate at which the hormones are formed and eliminated by the participant's body.


Eligibility Criteria
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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 Polycystic Ovary Syndrome (PCOS)
  • Participants with a Body Mass Index (BMI) of 18.5 to 38kg/m2 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 may 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)
  • Participants with surgical history of hysterectomy, unilateral or bilateral oophorectomy, bilateral tubal ligation, bilateral tubal occlusion, or bilateral salpingectomy
Contacts and Locations
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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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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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
Last Update Posted: August 4, 2020
Last Verified: July 2020
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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases