Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

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.

Completed

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Key information

Conditions

Hot Flashes Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Jundiaí, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Totelle®

Drug

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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life

Important dates

Study start: 2004
Study completion: 2006
First posted: Sep 19, 2005
Registry last updated: Aug 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed