Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hot Flashes Sleep Disorders

Keywords

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Menopause Sleep Disorder Hot Flashes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Totelle®

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Jundiaí, São Paulo, Brazil

Site Status

São Paulo, São Paulo, Brazil