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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 : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE August 12, 2019
Estimated Primary Completion Date March 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03951077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Official Title  ICMJE Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Brief Summary This study will assess the potential impact of Elagolix on disordered pituitary and ovarian hormones in women with Polycystic Ovary Syndrome (PCOS).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: Elagolix
    Capsule administered orally
    Other Name: Orilissa
  • Drug: Placebo
    Capsule administered orally
Study Arms  ICMJE
  • Experimental: Various doses of Elagolix plus matching placebo
    Various dosing regimens for Elagolix taken orally plus matching placebo taken orally depending on arm assignment.
    Interventions:
    • Drug: Elagolix
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo taken orally twice a day (BID)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 14, 2021
Estimated Primary Completion Date March 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951077
Other Study ID Numbers  ICMJE M16-837
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP