Conditions: Vasomotor Symptoms Hot Flashes
Keywords: Vasomotor symptom relief Postmenopausal women Severe to Moderate Vasomotor symptoms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 735
Healthy volunteers: no

Brief 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.

Arms:
arm 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 3: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). arm 4: Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Interventions: intervention 1: 0.5mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 3: Estradiol (E2 0.3mg) intervention 4: Placebo
Intervention descriptions: intervention 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 3: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). intervention 4: Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Protocol document: