An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

Study Identifier
M12-673
CT.gov Identifier
NCT01403038
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Women's Health & Pregnancy - Other
    • Study Drug
  • Elagolix
  • elagolix
    • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 40 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Premenopausal female, between 18 and 40 years of age, inclusive - History of regular menstrual cycles - Endocrine and ultrasonographic evidence of ovulation and normal ovulatory cycle during the screening period - Follicle-stimulating hormone level of \<35 mIU/mL - Agrees to use required birth control methods during the entire length of participation in the study
    Exclusion Criteria:
    \- Screening ultrasound results show a clinically significant gynecological disorder - Surgical history of hysterectomy without oophorectomy, unilateral or bilateral oophorectomy, removal of ovarian cysts - Less than 6 months postpartum or post-lactation at the start of study drug dosing - Pregnant or breast feeding or is planning a pregnancy within the next 12 months - Testosterone concentration \>120 ng/dL at screening

    Protocol Summary

    This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 50805
    Colorado Springs, Colorado, United States, 80910
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51270
    Colorado Springs, Colorado, United States, 80917
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50884
    Denver, Colorado, United States, 80246
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50404
    Lonetree, Colorado, United States, 80124
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50904
    Miami, Florida, United States, 33126
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50402
    South Miami, Florida, United States, 33143
    Status
    Not applicable
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