Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle

Sponsor
University of Southern California
Study ID
NCT04060992
Phase
PHASE4
Status
Unknown

Conditions

  • Ovulation; Failure or Lack of

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is twofold: First, to see if elagolix can suppress gonadotropin and ovarian hormones in the short-term period, when only administered for a 72-hour period. If elagolix effectively suppresses gonadotropin and ovarian hormones in a timely manner, it could be used to alter aspects of the menstrual cycle, depending on when administered. Second, is there a window for when elagolix functions best? While other studies initiate elagolix at the start of a woman's menstrual cycle, investigators of this study want to determine if administering elagolix at various points in a woman's menstrual cycle alters its ability to suppress gonadal and ovarian hormones.

Key Dates

Start date
Oct 1, 2019
Status verified
Aug 2019
Primary completion
Oct 30, 2020
Completion
Jul 1, 2021

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Early Follicular Phase
    Women enrolled will be anywhere from cycle day 1 through 5 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total.
  • Active Comparator: Late Follicular Phase
    Women enrolled will be anywhere from cycle day 8 through 13 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total.
  • Active Comparator: Luteal Phase
    Women enrolled will be anywhere from cycle day 21 through cycle day 26 of their menstrual cycle and take elagolix 200mg oral tablet BID for 3 days total.

Primary Outcome Measure

Suppression of gonadotropin and pituitary hormones as measured by hormonal assay status post short-term administration of elagolix [ Time Frame: measured over 4 days ]

Central Contacts