Trials / Completed
CompletedNCT00356447
Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-day Treatment Cycles.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 249 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Estradiol/DRSP (Angeliq, BAY86-4891) | Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration. |
| DRUG | Placebo | Same administration. |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2007-10-01
- Completion
- 2007-10-01
- First posted
- 2006-07-26
- Last updated
- 2014-10-01
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT00356447. Inclusion in this directory is not an endorsement.