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

NCT00615251 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1297

Last updated 2013-09-13

No results posted yet for this 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

Interventions

DRUG

DR-2011

Progesterone vaginal ring for approximately 10 weeks

DRUG

Crinone 8%

progesterone vaginal gel for approximately 10 weeks

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Principal Investigators

  • Duramed Research Protocol Chair · Duramed Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00615251 on ClinicalTrials.gov