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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

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