Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

Bayer

Status and phase: Completed; Phase 2

Conditions: Hypertension; Pre-Hypertension; Postmenopause

Treatments: Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891); Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420342

310522 (Other Identifier)

91507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women 45 - 65 years old with prehypertension

Exclusion criteria

• Hormone therapy (estrogen/progestin)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 3 patient groups

0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)

Experimental group

Description:

0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

Treatment:

Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)

Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)

2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)

Experimental group

Description:

2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

Treatment:

Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)

Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)

1.5 mg MPA / 0.3 mg CEE (Prempro)

Active Comparator group

Description:

1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

Treatment:

Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)