A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

August 30, 2013 updated by: Duramed Research

A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization

This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1297

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tarzana, California, United States, 91356
        • Duramed Investigational Site
      • West Lake, California, United States, 91361
        • Duramed Investigational Site
      • West Los Angeles, California, United States, 90064
        • Duramed Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33759
        • Duramed Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Duramed Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Duramed Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Duramed Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Duramed Investigational Site
      • Highland Park, Illinois, United States, 60035
        • Duramed Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Duramed Investigational Site
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Duramed Investigational Site
      • Flint, Michigan, United States, 48503
        • Duramed Investigational Site
      • Rochester Hills, Michigan, United States, 48307
        • Duramed Investigational Site
      • Saginaw, Michigan, United States, 48604
        • Duramed Investigational Site
      • Ypsilanti, Michigan, United States, 48197
        • Duramed Investigational Site
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Duramed Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89511
        • Duramed Investigational Site
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Duramed Investigational Site
      • Morristown, New Jersey, United States, 07960
        • Duramed Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45209
        • Duramed Investigational Site
      • Sylvania, Ohio, United States, 43560
        • Duramed Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Duramed Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Duramed Investigational Site
      • Myrtle Beach, South Carolina, United States, 29577
        • Duramed Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Duramed Investigational Site
      • Beaumont, Texas, United States, 77706
        • Duramed Investigational Site
      • Bedford, Texas, United States, 76022
        • Duramed Investigational Site
      • Webster, Texas, United States, 77598
        • Duramed Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pre-menopausal, aged 18-42 old at time of consent
  • At least one cycle without fertility medication prior to screening
  • Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
  • Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
  • Others as indicated by FDA-approved protocol

Exclusion Criteria:

  • Any contraindication to progesterone therapy
  • BMI > 38 kg/m2
  • Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)
  • History of more than 1 failed fresh IVF cycles
  • More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
  • Others as indicated by FDA-approved protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: DR-2011
Progesterone vaginal ring for approximately 10 weeks
Active Comparator: 2
Drug: Crinone 8%
progesterone vaginal gel for approximately 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
Time Frame: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Duration of study
Duration of study
Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
Time Frame: Duration of study
Duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-PGN-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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