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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615251
• Other study ID #: DR-PGN-302
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2008
• Last updated: August 30, 2013
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1297
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• DR-2011
Progesterone vaginal ring for approximately 10 weeks
• Crinone 8%
progesterone vaginal gel for approximately 10 weeks

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Alpharetta	Georgia
United States	Duramed Investigational Site	Atlanta	Georgia
United States	Duramed Investigational Site	Austin	Texas
United States	Duramed Investigational Site	Beaumont	Texas
United States	Duramed Investigational Site	Bedford	Texas
United States	Duramed Investigational Site	Boise	Idaho
United States	Duramed Investigational Site	Chicago	Illinois
United States	Duramed Investigational Site	Cincinnati	Ohio
United States	Duramed Investigational Site	Clearwater	Florida
United States	Duramed Investigational Site	Columbia	South Carolina
United States	Duramed Investigational Site	Dearborn	Michigan
United States	Duramed Investigational Site	Flint	Michigan
United States	Duramed Investigational Site	Highland Park	Illinois
United States	Duramed Investigational Site	Marlton	New Jersey
United States	Duramed Investigational Site	Morristown	New Jersey
United States	Duramed Investigational Site	Mount Pleasant	South Carolina
United States	Duramed Investigational Site	Myrtle Beach	South Carolina
United States	Duramed Investigational Site	Norfolk	Virginia
United States	Duramed Investigational Site	Reno	Nevada
United States	Duramed Investigational Site	Rochester Hills	Michigan
United States	Duramed Investigational Site	Rockville	Maryland
United States	Duramed Investigational Site	Saginaw	Michigan
United States	Duramed Investigational Site	Sylvania	Ohio
United States	Duramed Investigational Site	Tarzana	California
United States	Duramed Investigational Site	Webster	Texas
United States	Duramed Investigational Site	West Lake	California
United States	Duramed Investigational Site	West Los Angeles	California
United States	Duramed Investigational Site	Woodbury	Minnesota
United States	Duramed Investigational Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy		8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)	No
Secondary	Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy		Duration of study	No
Secondary	Adverse events		Duration of study	Yes