Trials / Completed
CompletedNCT03067727
A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term (41 Weeks of Gestation) Requiring Cervical Ripening
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-04-03
- Primary completion
- 2018-08-30
- Completion
- 2018-08-30
- First posted
- 2017-03-01
- Last updated
- 2020-11-03
Locations
20 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03067727. Inclusion in this directory is not an endorsement.