Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195520
• Other study ID #: 0753T-101537
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: August 1, 2008
• Start date: December 2004
• Est. completion date: December 2006

Study information

• Verified date: August 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• Totelle®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the effects of Totelle 1 mg on sexual function and quality of life.