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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2006

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Adequate endometrial transformation
  • Time Frame: Cycle Day 25 or 26
    Safety Issue?: No

Secondary Measures

• Hormone levels
  • Time Frame: Duration of study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Protocol Chair Study Chair Duramed Research, Inc,  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00117468

Study ID Number: DR-PGN-201

ClinicalTrials.gov Identifier: NCT00117468

Health Authority: United States: Food and Drug Administration

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