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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duramed Research
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Not pregnant

• Clinically or medically-induced non-functioning or surgically removed ovaries

• Clinical investigator believes patient would be eligible for oocyte donation

Exclusion Criteria:

• 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