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Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery

NCT02225353 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2018-10-23

Study results available
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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.

Conditions

Interventions

DRUG

Progesterone Cervical Pessary 6.3 g

Progesterone Cervical Pessary low dose

DRUG

Progesterone 200 mg vaginal capsules

Progesterone 200 mg vaginal capsules daily

DRUG

Progesterone Cervical Pessary 7.7 g

Progesterone Cervical Pessary high dose

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-02
Primary Completion
2017-03-13
Completion
2017-03-13

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225353 on ClinicalTrials.gov