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

Completed · Phase 1

Conditions studied: Folliculogenesis

In brief

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.

Key facts

Study ID

NCT01403038

Run by

AbbVie (prior sponsor, Abbott)

People needed

216

Starts

2011-06-01

Expected to finish

2012-11-01

Last updated by the study team

2013-01-08

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 50805 — Colorado Springs, Colorado, United States
• Site Reference ID/Investigator# 51270 — Colorado Springs, Colorado, United States
• Site Reference ID/Investigator# 50884 — Denver, Colorado, United States
• Site Reference ID/Investigator# 50404 — Lonetree, Colorado, United States
• Site Reference ID/Investigator# 50904 — Miami, Florida, United States
• Site Reference ID/Investigator# 50402 — South Miami, Florida, United States
• Site Reference ID/Investigator# 50808 — Tampa, Florida, United States
• Site Reference ID/Investigator# 50807 — Naperville, Illinois, United States
• Site Reference ID/Investigator# 50804 — Oak Brook, Illinois, United States
• Site Reference ID/Investigator# 50762 — Durham, North Carolina, United States
• Site Reference ID/Investigator# 50403 — Winston-Salem, North Carolina, United States
• Site Reference ID/Investigator# 50810 — Cincinnati, Ohio, United States
• Site Reference ID/Investigator# 50883 — Portland, Oregon, United States
• Site Reference ID/Investigator# 50803 — Philadelphia, Pennsylvania, United States
• Site Reference ID/Investigator# 51546 — Philadelphia, Pennsylvania, United States
• Site Reference ID/Investigator# 50806 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 51342 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 50811 — Sandy City, Utah, United States
• Site Reference ID/Investigator# 50902 — Norfolk, Virginia, United States
• Site Reference ID/Investigator# 50882 — Seattle, Washington, United States
• Site Reference ID/Investigator# 53363 — San Juan, Puerto Rico
• Site Reference ID/Investigator# 53362 — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.