Status:

COMPLETED

Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Lead Sponsor:

Upsher-Smith Laboratories

Conditions:

Postmenopausal Symptoms

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

July 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2005

Estimated Enrollment :

495 Patients enrolled

Trial Details

Trial ID

NCT00727129

Start Date

July 1 2004

End Date

August 1 2005

Last Update

September 26 2008

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