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

Completed · Phase 3

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT00615251

Run by

Duramed Research

People needed

1297

Starts

2008-02-01

Expected to finish

2009-08-01

Last updated by the study team

2013-09-13

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duramed Investigational Site — Tarzana, California, United States
• Duramed Investigational Site — West Los Angeles, California, United States
• Duramed Investigational Site — Westlake, California, United States
• Duramed Investigational Site — Clearwater, Florida, United States
• Duramed Investigational Site — Alpharetta, Georgia, United States
• Duramed Investigational Site — Atlanta, Georgia, United States
• Duramed Investigational Site — Boise, Idaho, United States
• Duramed Investigational Site — Chicago, Illinois, United States
• Duramed Investigational Site — Highland Park, Illinois, United States
• Duramed Investigational Site — Rockville, Maryland, United States
• Duramed Investigational Site — Dearborn, Michigan, United States
• Duramed Investigational Site — Flint, Michigan, United States
• Duramed Investigational Site — Rochester Hills, Michigan, United States
• Duramed Investigational Site — Saginaw, Michigan, United States
• Duramed Investigational Site — Ypsilanti, Michigan, United States
• Duramed Investigational Site — Woodbury, Minnesota, United States
• Duramed Investigational Site — Reno, Nevada, United States
• Duramed Investigational Site — Marlton, New Jersey, United States
• Duramed Investigational Site — Morristown, New Jersey, United States
• Duramed Investigational Site — Cincinnati, Ohio, United States
• Duramed Investigational Site — Sylvania, Ohio, United States
• Duramed Investigational Site — Columbia, South Carolina, United States
• Duramed Investigational Site — Mt. Pleasant, South Carolina, United States
• Duramed Investigational Site — Myrtle Beach, South Carolina, United States
• Duramed Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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