Endometrial Safety Study

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

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

Details

• Lead Sponsor: Bayer
• Collaborators: Diagnostic Cytology Laboratory; Laboratorium für Klinische Forschung; University of California, San Francisco
• Treatments: Drospirenone; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Norethindrone; Norethindrone acetate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)

• Non-hysterectomized women.

Exclusion Criteria:

• Usual exclusion criteria for hormone therapy apply.