NCT00117468

Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	DR-2011	Administered vaginally from Day 14 to Day 31
DRUG	Progesterone 8% Vaginal Gel	Administered vaginally from Cycle Day 14 to Day 31

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2005-07-07
• Last updated: 2014-05-12

Locations

1 site across 1 country: United States