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

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: Progesterone 8% Vaginal Gel; Drug: DR-2011

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117468

DR-PGN-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: DR-2011

2

Active Comparator group

Treatment:

Drug: Progesterone 8% Vaginal Gel