Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Tibolone

Criteria

Inclusion Criteria:

• Generally healthy postmenopausal women

• Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period

• At least 1 year of natural occurring amenorrhea

Exclusion Criteria:

• Known or suspected estrogen-dependent neoplasia

• Endometrial hyperplasia

• Any malignancy with the exception of a history of basal cell carcinoma of the skin