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NCT01953679 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days
A Phase 2 study, sponsored by Premier Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT01953679: Completed Phase 2 study, sponsored by Premier Research.
NCT01953679 is a Phase 2 study that has completed, run by Premier Research. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01953679, a Phase 2 study, has completed, sponsored by Premier Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.
Primary Outcome
* Two consecutive serum progesterone values ≥10nMol/L (3ng/mL) within a four day window; * A follicle ≥13 mm followed by a single serum progesterone value ≥10nMol/L (3ng/mL) without a second high progesterone level but with follicle disappearance, suggestive of follicular rupture.
Interventions
- DRUG Ulipristal Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
What the finished NCT01953679 record still lists
NCT01953679 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which Ulipristal Acetate is the first listed.
NCT01953679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01953679 about?
NCT01953679 is a clinical study titled "Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days". To compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg.
What is the current status of trial NCT01953679?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2014-03. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01953679?
The interventions under investigation include: Ulipristal Acetate (DRUG).
Who is sponsoring clinical trial NCT01953679?
This trial is sponsored by Premier Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01953679's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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