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Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195520
First Posted: September 19, 2005
Last Update Posted: August 5, 2008
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00195520     History of Changes
Other Study ID Numbers: 0753T-101537
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: August 5, 2008
Last Verified: August 2008

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

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