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

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

July 23, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adequate endometrial transformation [ Time Frame: Cycle Day 25 or 26 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Adequate endometrial transformation

Change History

Complete list of historical versions of study NCT00117468 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hormone levels [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Hormone levels

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

Brief Summary

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

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 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Infertility

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00117468

Responsible Party

Duramed Protocol Chair, Duramed Research, Inc.

Study ID Numbers ^ICMJE

DR-PGN-201

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc,

Information Provided By

Duramed Research

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP