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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT01403038

Public ClinicalTrials.gov record NCT01403038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01403038
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
AbbVie (prior sponsor, Abbott)
Industry
Enrollment
216 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 40 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2011
Primary completion
Sep 30, 2012
Completion
Oct 31, 2012
Last update posted
Jan 7, 2013

2011 – 2012

United States locations

U.S. sites
20
U.S. states
11
U.S. cities
17
Facility City State ZIP Site status
Site Reference ID/Investigator# 50805 Colorado Springs Colorado 80910
Site Reference ID/Investigator# 51270 Colorado Springs Colorado 80917
Site Reference ID/Investigator# 50884 Denver Colorado 80246
Site Reference ID/Investigator# 50404 Lonetree Colorado 80124
Site Reference ID/Investigator# 50904 Miami Florida 33126
Site Reference ID/Investigator# 50402 South Miami Florida 33143
Site Reference ID/Investigator# 50808 Tampa Florida 33606
Site Reference ID/Investigator# 50807 Naperville Illinois 60540
Site Reference ID/Investigator# 50804 Oak Brook Illinois 60523
Site Reference ID/Investigator# 50762 Durham North Carolina 27713
Site Reference ID/Investigator# 50403 Winston-Salem North Carolina 27103
Site Reference ID/Investigator# 50810 Cincinnati Ohio 45267-0457
Site Reference ID/Investigator# 50883 Portland Oregon 97239
Site Reference ID/Investigator# 50803 Philadelphia Pennsylvania 19104
Site Reference ID/Investigator# 51546 Philadelphia Pennsylvania 19114
Site Reference ID/Investigator# 50806 San Antonio Texas 78229
Site Reference ID/Investigator# 51342 San Antonio Texas 78229
Site Reference ID/Investigator# 50811 Sandy City Utah 84070
Site Reference ID/Investigator# 50902 Norfolk Virginia 23507
Site Reference ID/Investigator# 50882 Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01403038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 7, 2013 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01403038 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →