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

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Southern California
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.