Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
NCT00195520
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function | |||
| Official Title ICMJE | An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: Totelle® | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Estimated Enrollment ICMJE | 100 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | December 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 45 Years to 60 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Brazil | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00195520 | |||
| Other Study ID Numbers ICMJE | 0753T-101537 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | August 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||