Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Lead Sponsor:
Duramed Research
Conditions:
Menopause
Eligibility:
FEMALE
30-80 years
Phase:
PHASE3
Brief Summary
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal a...
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 phy...
Eligibility Criteria
Inclusion
- Naturally or surgically menopausal
- 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 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 :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
622 Patients enrolled
Trial Details
Trial ID
NCT00361569
Start Date
August 1 2006
End Date
September 1 2007
Last Update
April 20 2015
Active Locations (97)
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1
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
2
Duramed Investigational Site
Mobile, Alabama, United States, 36608
3
Duramed Investigational Site
Montgomery, Alabama, United States, 36608
4
Duramed Investigational Site
Phoenix, Arizona, United States, 85015