Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195520
First received: September 12, 2005
Last updated: August 1, 2008
Last verified: August 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Jundiai, Sao Paulo, Brazil, 13209-000
Sao Paulo, Brazil, 04062-003
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Menopause
Sleep Disorder
Hot Flashes

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Hot Flashes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014