NCT00446199

Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Oral Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 735 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Detailed description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Conditions

• Vasomotor Symptoms
• Hot Flashes

Interventions

Type	Name	Description
DRUG	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
DRUG	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).
DRUG	Estradiol (E2 0.3mg)	One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).
DRUG	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2007-03-12
• Last updated: 2015-05-06
• Results posted: 2012-04-18

Locations

76 sites across 1 country: United States