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CompletedNCT00195520Updated Aug 5, 2008

Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

A Phase 4 interventional study of Totelle® in Hot Flashes and Sleep Disorders, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 2 sites in Brazil. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-08-05.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
45 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Hot Flashes
  • Sleep Disorders

Keywords

  • Menopause
  • Sleep Disorder
  • Hot Flashes
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's planned enrollment of 100 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • DrugTotelle®
06

What researchers measure

Primary outcomes

  1. 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

  1. To evaluate the effects of Totelle 1 mg on sexual function and quality of life.

07

Study locations

2 sites
  • Jundiai, Sao Paulo 13209-000, Brazil
  • Sao Paulo, 04062-003, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00195520
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Sep 19, 2005
Start date
Dec 2004
Completion
Dec 2006
Last update
Aug 5, 2008

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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