Trials / Completed
CompletedNCT00511797
SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
A Multicenter, Double-blind, Randomized, Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 249 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SH T04740B | Drospirenone 1mg/EE 20µg (ß-CDC) |
| DRUG | SH T00186DF | Drospirenone 3 mg/EE 20µg (ß-CDC) |
| DRUG | SH T04740F | Drospirenone 2 mg/EE 20µg (ß-CDC) |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2007-08-06
- Last updated
- 2017-01-26
- Results posted
- 2010-10-04
Locations
12 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00511797. Inclusion in this directory is not an endorsement.