At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 36 enrolled
Drug / intervention
oral micronized progesterone +1 moredrug
Likely dose
oral micronized progesterone 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prevention of Recurrent Preterm Birth With Micronized Progesterone
In Brief
A Phase 3 clinical trial evaluating oral micronized progesterone and Identical Placebo tablet for Preterm Birth. Completed, enrolled 36 participants across 1 site.
Detailed Summary
To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2006
Primary CompletionJan 2009
First PostedAug 2010
TodayJul 2026
First PostedAug 12, 2010
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.9 years ago
Interventions
oral micronized progesteronedrug
oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
Identical Placebo tabletdrug
Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks