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Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00727129
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:
Upsher-Smith Laboratories

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

Condition or disease Intervention/treatment Phase
Postmenopausal Symptoms Drug: Divigel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. vulvar and vaginal atrophy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Additional Information:
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
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

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

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