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COMPLETED Phase 3

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

NCT00615251 · View on ClinicalTrials.gov ↗

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

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

4 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,297 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00615251 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Michigan, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00615251?

The interventions under investigation include: DR-2011 (DRUG), Crinone 8% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00615251?

This trial is sponsored by Duramed Research, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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