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

Completed · Phase 2

Conditions studied: Infertility

In brief

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

Key facts

Study ID

NCT00117468

Run by

Duramed Research

People needed

20

Starts

2005-06-01

Expected to finish

2006-04-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Not pregnant
• Clinically or medically-induced non-functioning or surgically removed ovaries
• Clinical investigator believes patient would be eligible for oocyte donation

You may not qualify if…

• 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

Where it is running

• Duramed Investigational Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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