Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
Lead Sponsor:
Duramed Research
Conditions:
Menopause
Eligibility:
FEMALE
30-80 years
Phase:
PHASE3
Brief Summary
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovagina...
Detailed Description
The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo phys...
Eligibility Criteria
Inclusion
- Naturally or surgically postmenopausal
- Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Exclusion
- Known sensitivity or contraindication to estrogens or progestins
- History or current diagnosis of endometrial hyperplasia
- Recent history of vaginal bleeding of unknown cause
- Recent history or diagnosis of endometriosis
- Any contraindication to estrogen therapy
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00196378
Start Date
November 1 2004
End Date
February 1 2006
Last Update
September 2 2013
Active Locations (38)
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1
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
2
Duramed Investigational Site
Tucson, Arizona, United States, 85712
3
Duramed Investigational Site
Carmichael, California, United States, 95608
4
Duramed Investigational Site
San Diego, California, United States, 92103