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A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

NCT03067727 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-11-03

No results posted yet for this study

Summary

To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration

Conditions

  • Cervical Ripening

Interventions

DRUG

Dinoprostone

The DVI contains 10 mg Dinoprostone

DRUG

Placebo

The placebo product is identical with the active product except that it does not contain Dinoprostone.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2018-08-30
Completion
2018-08-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

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 NCT03067727 on ClinicalTrials.gov