Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Phase 3CompletedNCT00727129

Upsher-Smith Laboratories495 enrolled

Overview

The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

495

Conditions

Postmenopausal Symptoms

Interventions

DivigelDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women * Have moderate to severe hot flashes * Normal Pap Smear Exclusion Criteria: * Abnormal mammogram * Abnormal clinical breast exam * BMI \>35

Outcomes

Primary Outcomes

Daily frequency and severity of moderate to severe vasomotor symptoms

Secondary Outcomes

vulvar and vaginal atrophy

Data from ClinicalTrials.gov

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