Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

Bayer

Status and phase: Completed; Phase 3

Conditions: Hot Flashes; Vasomotor Symptoms

Treatments: Drug: Placebo; Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891); Drug: Estradiol (E2 0.3mg); Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446199

91493

310184 (Other Identifier)

Details and patient eligibility

About

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.

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: 735 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion criteria

• The usual exclusion criteria for hormone therapy apply
• Intake of medications other than hormones affecting hot flushes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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735 participants in 4 patient groups, including a placebo group

0.5mg DRSP / 0.5mg E2 (BAY86-4891)

Experimental group

Description:

One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

Treatment:

Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)

0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Experimental group

Description:

One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

Treatment:

Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Estradiol (E2 0.3mg)

Experimental group

Description:

One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).

Treatment:

Drug: Estradiol (E2 0.3mg)

Placebo

Placebo Comparator group

Description:

Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Treatment:

Drug: Placebo