Status:
UNKNOWN
Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle
Lead Sponsor:
University of Southern California
Conditions:
Ovulation; Failure or Lack of
Eligibility:
FEMALE
18-39 years
Phase:
PHASE4
Brief Summary
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 effect...
Detailed Description
Gonadotropin-releasing hormone (GnRH) and its analogs have been utilized in clinical medicine since the early 1970s. The GnRH analog is more potent with a longer half-life than native GnRH. When admin...
Eligibility Criteria
Inclusion
- Healthy volunteers from USC Fertility
- Documented ovulation with a serum mid-luteal progesterone ≥3pg/mL
- Ovulatory with a 24-35-day cycle
- Ages 18-39
- Body Mass Index (BMI) 18.1-30.0kg/m2
- Consistent condom use for contraception
- Not desiring or seeking pregnancy
Exclusion
- Allergy to injectable or oral GnRH-antagonist
- FSH ≥ 10 IU/L or LH ≥ 10 IU/L in early follicular phase iii. Known liver disease iv. Known osteoporosis v. Pregnancy vi. Current use of drugs metabolized by the liver enzyme CYP3A, specifically ketoconazole, rifampin, digoxin, oral midazolam, or rosuvastatin.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04060992
Start Date
October 1 2019
End Date
July 1 2021
Last Update
August 19 2019
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