Status:
COMPLETED
Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Lead Sponsor:
Duramed Research
Conditions:
Infertility
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.
Detailed Description
This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day t...
Eligibility Criteria
Inclusion
- Not pregnant
- Clinically or medically-induced non-functioning or surgically removed ovaries
- Clinical investigator believes patient would be eligible for oocyte donation
Exclusion
- Any contraindication to progesterone or estrogen therapy
- Undiagnosed vaginal bleeding
- History of uterine fibroids or any other conditions that could adversely affect pregnancy success
- Hysterectomy
- Any contraindication to vaginal drug delivery systems
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00117468
Start Date
June 1 2005
End Date
April 1 2006
Last Update
May 12 2014
Active Locations (1)
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1
Duramed Investigational Site
Norfolk, Virginia, United States, 23507