Status:
COMPLETED
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hot Flashes
Sleep Disorders
Eligibility:
FEMALE
45-60 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00195520
Start Date
December 1 2004
End Date
December 1 2006
Last Update
August 5 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Jundiaí, São Paulo, Brazil, 13209-000
2
São Paulo, São Paulo, Brazil, 04062-003