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NCT00615251 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Infertility, sponsored by Duramed Research.

Completed
Registry status
Phase 3
Development phase
1,297
Enrollment target
20
Study locations

NCT00615251 is a Phase 3 study of Infertility that has completed, run by Duramed Research. The registered enrollment target is 1,297 participants, below the 7,572-participant average among 74 other Infertility trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00615251, a Phase 3 study of Infertility, has completed, sponsored by Duramed Research.

COMPLETED
Registry status
Phase 3
Development phase
1,297 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Infertility

Interventions

  • DRUG DR-2011
  • DRUG Crinone 8%

Study Locations (20)

Michigan

  • Duramed Investigational Site - Dearborn
  • Duramed Investigational Site - Flint
  • Duramed Investigational Site - Rochester Hills
  • Duramed Investigational Site - Saginaw
  • Duramed Investigational Site - Ypsilanti

California

  • Duramed Investigational Site - Tarzana
  • Duramed Investigational Site - West Los Angeles
  • Duramed Investigational Site - Westlake

Georgia

  • Duramed Investigational Site - Alpharetta
  • Duramed Investigational Site - Atlanta

Illinois

  • Duramed Investigational Site - Chicago
  • Duramed Investigational Site - Highland Park

New Jersey

  • Duramed Investigational Site - Marlton
  • Duramed Investigational Site - Morristown

Florida

  • Duramed Investigational Site - Clearwater

Idaho

  • Duramed Investigational Site - Boise

Maryland

  • Duramed Investigational Site - Rockville

Trial Details

FieldValue
Enrollment Target 1,297 participants
Start Date 2008-02
Est. Completion 2009-08
Phase Phase 3

Sponsor

Duramed Research

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00615251

The ClinicalTrials.gov registry entry for NCT00615251 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,297 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,572-participant average among 74 other Infertility trials with a reported enrollment target (83% lower). The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infertility appearing as the primary indexed condition, and to 2 interventions - of which DR-2011 is the first listed.

NCT00615251 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Michigan, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT00615251 about?

NCT00615251 is a clinical study titled "A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 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.

What is the current status of trial NCT00615251?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,297 participants. The study started on 2008-02. Estimated completion is 2009-08.

What conditions does trial NCT00615251 study?

This clinical trial studies the following conditions: Infertility.

What interventions are being tested in trial NCT00615251?

The interventions under investigation include: DR-2011 (DRUG), Crinone 8% (DRUG).

Who is sponsoring clinical trial NCT00615251?

This trial is sponsored by Duramed Research, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00615251 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.