Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Criteria

Inclusion Criteria:

• Intact uterus

• Generally health postmenopausal women 45 to 60 years of age, inclusive

• Sexually active

• No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.

Exclusion Criteria:

• Known or suspect estrogen-dependent neoplasia

• Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle

• Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.