Status:
COMPLETED
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Neurocrine Biosciences
Conditions:
Folliculogenesis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief 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 t...
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 ...
Eligibility Criteria
Inclusion
- \- 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
Exclusion
- \- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01403038
Start Date
June 1 2011
End Date
November 1 2012
Last Update
January 8 2013
Active Locations (22)
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1
Site Reference ID/Investigator# 50805
Colorado Springs, Colorado, United States, 80910
2
Site Reference ID/Investigator# 51270
Colorado Springs, Colorado, United States, 80917
3
Site Reference ID/Investigator# 50884
Denver, Colorado, United States, 80246
4
Site Reference ID/Investigator# 50404
Lonetree, Colorado, United States, 80124