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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
History of Changes
  Purpose

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


Condition Intervention Phase
Postmenopausal Symptoms
 Drug: Divigel
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Upsher-Smith Laboratories:

Primary Outcome Measures:
  • Daily frequency and severity of moderate to severe vasomotor symptoms

Secondary Outcome Measures:
  • vulvar and vaginal atrophy

Enrollment: 495
Study Start Date: July 2004
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Abnormal mammogram
  • Abnormal clinical breast exam
  • BMI >35
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:
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.

Responsible Party: Upsher-Smith (Medical Affairs), Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT00727129     History of Changes
Other Study ID Numbers: P04-001
Study First Received: July 29, 2008
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Upsher-Smith Laboratories:
vasomotor symptoms
estrogen
estradiol
hot flashes

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 21, 2013