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Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

This study has been completed.
Sponsor:
Information provided by:
Upsher-Smith Laboratories
ClinicalTrials.gov Identifier:
NCT00727129
First received: July 29, 2008
Last updated: September 25, 2008
Last verified: September 2008

July 29, 2008
September 25, 2008
July 2004
Not Provided
Daily frequency and severity of moderate to severe vasomotor symptoms
Same as current
Complete list of historical versions of study NCT00727129 on ClinicalTrials.gov Archive Site
vulvar and vaginal atrophy
Same as current
Not Provided
Not Provided
 
Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Postmenopausal Symptoms
Drug: Divigel
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
495
August 2005
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Abnormal mammogram
  • Abnormal clinical breast exam
  • BMI >35
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00727129
P04-001
Not Provided
Upsher-Smith (Medical Affairs), Upsher-Smith Laboratories
Upsher-Smith Laboratories
Not Provided
Not Provided
Upsher-Smith Laboratories
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP