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

Study Identifier
M16-837
CT.gov Identifier
NCT03951077
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English
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Study Details

Medical Condition
  • Women's Health & Pregnancy - Other
    • Study Drug
  • Elagolix
  • Placebo
    • Phase
    Phase 2
    Sex
    Female
    Age
    18 - 35 Years
    Inclusion and Exclusion 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).

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    Alabama Clinical Therapeutics /ID# 211498
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    Mobile, OBGYN P.C. /ID# 205574
    Mobile, Alabama, United States, 36608
    Status
    Not applicable
    Location
    Medical Ctr for Clin Research /ID# 205694
    San Diego, California, United States, 92108
    Status
    Not applicable
    Location
    UCSF Center for Reproductive Health /ID# 210836
    San Francisco, California, United States, 94158-2518
    Status
    Not applicable
    Location
    Avail Clinical Research /ID# 210873
    DeLand, Florida, United States, 32720-0834
    Status
    Not applicable
    Location
    University of FL Southside Women's Specialists /ID# 210872
    Jacksonville, Florida, United States, 32207-4918
    Status
    Not applicable
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