Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
- Registration Number
- NCT00117468
- Lead Sponsor
- Duramed Research
- 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 treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months.
Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- Not pregnant
- Clinically or medically-induced non-functioning or surgically removed ovaries
- Clinical investigator believes patient would be eligible for oocyte donation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Progesterone 8% Vaginal Gel - 1 DR-2011 -
- Primary Outcome Measures
Name Time Method Adequate endometrial transformation Cycle Day 25 or 26
- Secondary Outcome Measures
Name Time Method Hormone levels Duration of study
Trial Locations
- Locations (1)
Duramed Investigational Site
🇺🇸Norfolk, Virginia, United States