Back to resultsStudy Evaluating Totelle® in Menopausal Symptoms and Sexual Function
Primary Purpose
Hot Flashes, Sleep Disorders
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Totelle®
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring Menopause, Sleep Disorder, Hot Flashes
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
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 Outcome Measures
To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
Full Information
NCT ID
NCT00195520
First Posted
September 12, 2005
Last Updated
August 1, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195520
Brief Title
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
Official Title
An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Sleep Disorders
Keywords
Menopause, Sleep Disorder, Hot Flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Totelle®
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Jundiai
State/Province
Sao Paulo
ZIP/Postal Code
13209-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04062-003
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
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