Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195520

Purpose

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.

Condition	Intervention	Phase
Hot Flashes Sleep Disorders	Drug: Totelle®	Phase IV

MedlinePlus related topics: Hormone Replacement Therapy Menopause Sleep Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life

Further study details as provided by Wyeth:

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.

Estimated Enrollment:	100
Study Start Date:	December 2004
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	45 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195520

Locations

Brazil

Sao Paulo, Brazil, 04062-003
Brazil, Sao Paulo

Jundiai, Sao Paulo, Brazil, 13209-000

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0753T-101537
Study First Received:	September 12, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00195520
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Wyeth:

Menopause
Sleep Disorder
Hot Flashes

Study placed in the following topic categories:

Signs and Symptoms
Mental Disorders
Hot Flashes
Quality of Life

Neurologic Manifestations
Sleep Disorders
Menopause

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009