Trials / Completed
CompletedNCT03067597
An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
A Multicentre, Open-label Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term (≥37 Weeks and <41 Weeks of Gestation) Requiring Cervical Ripening
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dinoprostone | The DVI contains 10 mg dinoprostone |
Timeline
- Start date
- 2017-02-22
- Primary completion
- 2018-02-24
- Completion
- 2018-02-24
- First posted
- 2017-03-01
- Last updated
- 2021-04-09
Locations
14 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03067597. Inclusion in this directory is not an endorsement.