NCT00195520CompletedPhase 4
An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life
Wyeth is now a wholly owned subsidiary of Pfizer2 sites in 1 country100 target enrollmentStarted: December 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
Secondary Outcomes
- To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
Investigators
Study Sites (2)
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