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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

DR-2011

Progesterone 8% Vaginal Gel

About this trial

This is an interventional treatment trial for Infertility focused on measuring luteal phase replacement, oocyte donation, infertility, progesterone

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Duramed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Adequate endometrial transformation

Secondary Outcome Measures

Hormone levels

Full Information

NCT ID

NCT00117468

First Posted

June 30, 2005

Last Updated

May 9, 2014

Sponsor

Duramed Research

1. Study Identification

Unique Protocol Identification Number

NCT00117468

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Duramed Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

luteal phase replacement, oocyte donation, infertility, progesterone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

DR-2011

Intervention Description

Administered vaginally from Day 14 to Day 31

Intervention Type

Drug

Intervention Name(s)

Progesterone 8% Vaginal Gel

Other Intervention Name(s)

Crinone

Intervention Description

Administered vaginally from Cycle Day 14 to Day 31

Primary Outcome Measure Information:

Title

Adequate endometrial transformation

Time Frame

Cycle Day 25 or 26

Secondary Outcome Measure Information:

Title

Hormone levels

Time Frame

Duration of study

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Duramed Protocol Chair

Organizational Affiliation

Duramed Research, Inc,

Official's Role

Study Chair

Facility Information:

Facility Name

Duramed Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.nlm.nih.gov/medlineplus/infertility.html

Description

MedlinePlus - Infertility

Learn more about this trial

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

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