Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00195520|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Hot Flashes Sleep Disorders||Drug: Totelle®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life|
|Study Start Date :||December 2004|
|Actual Study Completion Date :||December 2006|
- 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.
- To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195520
|Jundiai, Sao Paulo, Brazil, 13209-000|
|Sao Paulo, Brazil, 04062-003|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|