NCT01403038

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

A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label, multiple-dose, Phase 1 study in premenopausal subjects aged 18 years to 40 years, with a history of regular menstrual cycles (24 to 32 days long) and no evidence of significant gynecological disorders. The objective of the study is to determine the effects of different dosing regimens of elagolix on ovulation, ovarian activity, and ovarian reserve. The study consists of 3 periods: a Screening Period of up to 50 days prior to the first dose, a Treatment Period of 3 months duration (Cycles 1-3), and a Follow-up Period of up to 60 days. During the Screening and Treatment menstrual cycles, serial transvaginal ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone, and inhibin B will be performed three times weekly. Subjects will maintain a daily diary of uterine bleeding. Pregnancy testing will be performed frequently throughout the study. Subjects will be required to use nonhormonal dual contraception consistently during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Conditions

• Folliculogenesis

Interventions

Type	Name	Description
DRUG	Elagolix	Elagolix Dose Regimen 1 for 84 days
DRUG	Elagolix	Elagolix Dose Regimen 2 for 84 days
DRUG	Elagolix	Elagolix Dose Regimen 3 for 84 days
DRUG	Elagolix	Elagolix Dose Regimen 4 for 84 days Other interventions may be added
DRUG	Elagolix	Elagolix Dose Regimen 5 for 84 days
DRUG	Elagolix	Elagolix Dose Regimen 6 for 84 days
DRUG	elagolix	Elagolix plus Activella Dose Regimen 7 for 84 days

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2011-07-27
• Last updated: 2013-01-08

Locations

22 sites across 2 countries: United States, Puerto Rico