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
1 other identifier
interventional
495
0 countries
N/A
Brief Summary
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2004
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 29, 2008
CompletedFirst Posted
Study publicly available on registry
August 1, 2008
CompletedSeptember 26, 2008
September 1, 2008
July 29, 2008
September 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Daily frequency and severity of moderate to severe vasomotor symptoms
Secondary Outcomes (1)
vulvar and vaginal atrophy
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women
- Have moderate to severe hot flashes
- Normal Pap Smear
You may not qualify if:
- Abnormal mammogram
- Abnormal clinical breast exam
- BMI \>35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 29, 2008
First Posted
August 1, 2008
Study Start
July 1, 2004
Study Completion
August 1, 2005
Last Updated
September 26, 2008
Record last verified: 2008-09