Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

Bayer

Status and phase: Completed; Phase 3

Conditions: Vasomotor Symptoms

Treatments: Drug: Placebo; Drug: Estradiol/DRSP (Angeliq, BAY86-4891)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356447

309341 (Other Identifier)

91442

Details and patient eligibility

About

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Enrollment: 249 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion criteria

• History of steroid hormone dependent malignant disease
• Known or suspected malignant or premalignant disease
• Current or history of severe heart, liver, renal, psychiatric disease
• Hyperlipemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

249 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: Estradiol/DRSP (Angeliq, BAY86-4891)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo