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NCT01004029 · ClinicalTrials.gov registry record · Phase 3
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
A Phase 3 study, sponsored by AMAG Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,740
- Enrollment target
NCT01004029: Completed Phase 3 study, sponsored by AMAG Pharmaceuticals.
NCT01004029 is a Phase 3 study that has completed, run by AMAG Pharmaceuticals. The registered enrollment target is 1,740 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01004029, a Phase 3 study, has completed, sponsored by AMAG Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,740 participants
- Enrollment target
Study Summary
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
Primary Outcome
Determine if treatment with 17P reduces the rate of preterm birth \< 35 weeks, 0 days of gestation in women with a previous singleton spontaneous preterm delivery.
Interventions
- DRUG Vehicle
- DRUG Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,740 participants |
| Start Date | 2009-10 |
| Est. Completion | 2018-10 |
| Phase | Phase 3 |
What the finished NCT01004029 record still lists
NCT01004029 is an interventional study that assigns participants to a tested intervention. Its 1,740 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01004029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01004029 about?
NCT01004029 is a clinical study titled "Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery". As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singlet...
What is the current status of trial NCT01004029?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,740 participants. The study started on 2009-10. Estimated completion is 2018-10.
What interventions are being tested in trial NCT01004029?
The interventions under investigation include: Vehicle (DRUG), Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL (DRUG).
Who is sponsoring clinical trial NCT01004029?
This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01004029's enrollment target sits among peer trials
1,740 129th of 2000 higher than 1,872 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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