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NCT00727129 Clinical Trial

Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Postmenopausal Symptoms Clinical Trial

Official title:
Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00727129
Other study ID # P04-001
Secondary ID
Status Completed
Phase Phase 3
First received July 29, 2008
Last updated September 25, 2008
Start date July 2004
Est. completion date August 2005

Study information
Verified date September 2008
Source Upsher-Smith Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 495
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Postmenopausal women

- Have moderate to severe hot flashes

- Normal Pap Smear

Exclusion Criteria:

- Abnormal mammogram

- Abnormal clinical breast exam

- BMI >35

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Divigel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Upsher-Smith Laboratories

References & Publications (1)

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.

Outcome
Type Measure Description Time frame Safety issue
Primary Daily frequency and severity of moderate to severe vasomotor symptoms
Secondary vulvar and vaginal atrophy
See also
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