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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: DR-2011 (Drug); Progesterone 8% Vaginal Gel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duramed Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc,

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adequate endometrial transformation

Secondary outcome: Hormone levels

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 1 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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

Duramed Investigational Site, Norfolk, Virginia 23507, United States
Additional Information

MedlinePlus - Infertility

Starting date: June 2005
Last updated: May 9, 2014

Page last updated: August 23, 2015

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