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NCT01403038 · ClinicalTrials.gov registry record · Phase 1
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
A Phase 1 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 1
- Development phase
- 216
- Enrollment target
NCT01403038: Completed Phase 1 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT01403038 is a Phase 1 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 216 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (260% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01403038, a Phase 1 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 216 participants
- Enrollment target
Study 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.
Primary Outcome
Presence or absence of ovulation
Interventions
- DRUG Elagolix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01403038 record still lists
NCT01403038 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (260% higher).
The record links to 0 conditions, and to 1 intervention - of which Elagolix is the first listed.
NCT01403038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01403038 about?
NCT01403038 is a clinical study titled "An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females". 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.
What is the current status of trial NCT01403038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 216 participants. The study started on 2011-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01403038?
The interventions under investigation include: Elagolix (DRUG).
Who is sponsoring clinical trial NCT01403038?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01403038's enrollment target sits among peer trials
216 243rd of 2000 higher than 1,758 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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