CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 271 enrolled
Drug / intervention
Progesterone Cervical Pessary 6.3 g +2 moredrug
Likely dose
Progesterone Cervical Pessary 6.3 gfrom 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.

Search/NCT02225353
NCT02225353Phase 2Completed
CompareCT.gov

A Randomized, Open-Label, Controlled, Multi-Center Study on the Efficacy of a Sustained Release Progesterone Cerclage Cervical Pessary at Doses of 6.3 g or 7.7 g for the Prevention of Preterm Birth and a Maximum Duration of 20 Weeks.

Grünenthal GmbH·interventional·Posted Aug 26, 2014·Updated Oct 23, 2018

In Brief

A Phase 2 clinical trial evaluating Progesterone Cervical Pessary 6.3 g, Progesterone 200 mg vaginal capsules, and 1 other intervention for Preterm Birth. Completed, enrolled 271 participants across 4 sites.

Detailed Summary

Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth
CountriesChile
CollaboratorsLaboratorios Andromaco S.A.

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 26, 2014
Enrollment StartSep 2, 2013
Primary CompletionMar 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.8 years ago

Interventions

Progesterone Cervical Pessary 6.3 gdrug

Progesterone Cervical Pessary low dose

Progesterone 200 mg vaginal capsulesdrug

Progesterone 200 mg vaginal capsules daily

Progesterone Cervical Pessary 7.7 gdrug

Progesterone Cervical Pessary high dose