Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement|
- Adequate endometrial transformation [ Time Frame: Cycle Day 25 or 26 ] [ Designated as safety issue: No ]
- Hormone levels [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Administered vaginally from Day 14 to Day 31
|Active Comparator: 2||
Drug: Progesterone 8% Vaginal Gel
Administered vaginally from Cycle Day 14 to Day 31
Other Name: Crinone
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.