Conditions: Postmenopause Hypertension Pre-Hypertension
Keywords: Pre-Hypertension in Postmenopausal Women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

Brief summary:
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.

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: 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 2: 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 3: 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

Interventions: intervention 1: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 2: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 3: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Intervention descriptions: intervention 1: SH K 00641 A -Active study medication encapsulated tablet intervention 2: SH K 00641 B - Active study medication encapsulated tablet intervention 3: Active control encapsulated tablet

Protocol document: