Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

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

PHASE3

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Postmenopausal Symptoms

Keywords

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vasomotor symptoms estrogen estradiol hot flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Divigel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women
* Have moderate to severe hot flashes
* Normal Pap Smear

Exclusion Criteria

* Abnormal mammogram
* Abnormal clinical breast exam
* BMI \>35

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Upsher-Smith Laboratories

References

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Hedrick RE. Low-dose estradiol gel 0.1% for the treatment of vasomotor symptoms associated with menopause. Expert Review of Obstetrics & Gynecology, 3(2): Pages 155-162, Mar 2008.

Reference Type RESULT

Other Identifiers

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P04-001

Identifier Type: -

Identifier Source: org_study_id