- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00615251
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
August 30, 2013 updated by: Duramed Research
A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1297
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Tarzana, California, United States, 91356
- Duramed Investigational Site
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West Lake, California, United States, 91361
- Duramed Investigational Site
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West Los Angeles, California, United States, 90064
- Duramed Investigational Site
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Florida
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Clearwater, Florida, United States, 33759
- Duramed Investigational Site
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Georgia
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Alpharetta, Georgia, United States, 30005
- Duramed Investigational Site
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Atlanta, Georgia, United States, 30342
- Duramed Investigational Site
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Idaho
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Boise, Idaho, United States, 83702
- Duramed Investigational Site
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Illinois
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Chicago, Illinois, United States, 60610
- Duramed Investigational Site
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Highland Park, Illinois, United States, 60035
- Duramed Investigational Site
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Maryland
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Rockville, Maryland, United States, 20850
- Duramed Investigational Site
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Michigan
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Dearborn, Michigan, United States, 48126
- Duramed Investigational Site
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Flint, Michigan, United States, 48503
- Duramed Investigational Site
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Rochester Hills, Michigan, United States, 48307
- Duramed Investigational Site
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Saginaw, Michigan, United States, 48604
- Duramed Investigational Site
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Ypsilanti, Michigan, United States, 48197
- Duramed Investigational Site
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Minnesota
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Woodbury, Minnesota, United States, 55125
- Duramed Investigational Site
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Nevada
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Reno, Nevada, United States, 89511
- Duramed Investigational Site
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New Jersey
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Marlton, New Jersey, United States, 08053
- Duramed Investigational Site
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Morristown, New Jersey, United States, 07960
- Duramed Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45209
- Duramed Investigational Site
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Sylvania, Ohio, United States, 43560
- Duramed Investigational Site
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South Carolina
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Columbia, South Carolina, United States, 29201
- Duramed Investigational Site
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Mount Pleasant, South Carolina, United States, 29464
- Duramed Investigational Site
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Myrtle Beach, South Carolina, United States, 29577
- Duramed Investigational Site
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Texas
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Austin, Texas, United States, 78731
- Duramed Investigational Site
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Beaumont, Texas, United States, 77706
- Duramed Investigational Site
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Bedford, Texas, United States, 76022
- Duramed Investigational Site
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Webster, Texas, United States, 77598
- Duramed Investigational Site
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Virginia
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Norfolk, Virginia, United States, 23507
- Duramed Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Progesterone vaginal ring for approximately 10 weeks
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Active Comparator: 2
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progesterone vaginal gel for approximately 10 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
Time Frame: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
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8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse events
Time Frame: Duration of study
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Duration of study
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Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
Time Frame: Duration of study
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Duration of study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ginsburg ES, Jellerette-Nolan T, Daftary G, Du Y, Silverberg KM. Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization. Fertil Steril. 2018 Nov;110(6):1101-1108.e3. doi: 10.1016/j.fertnstert.2018.07.014.
- Stadtmauer L, Silverberg KM, Ginsburg ES, Weiss H, Howard B. Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study. Fertil Steril. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
February 4, 2008
First Submitted That Met QC Criteria
February 4, 2008
First Posted (Estimate)
February 14, 2008
Study Record Updates
Last Update Posted (Estimate)
September 13, 2013
Last Update Submitted That Met QC Criteria
August 30, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR-PGN-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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