Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

Phase 4CompletedNCT00195520

Wyeth is now a wholly owned subsidiary of Pfizer100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hot Flashes Sleep Disorders

Interventions

Totelle®DRUG

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Jundiaí, São Paulo, Brazil

Unnamed facility

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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