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| Sponsored by: |
Duramed Research |
| Information provided by: | Duramed Research |
| ClinicalTrials.gov Identifier: | NCT00615251 |
Purpose
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.
| Condition | Intervention | Phase |
|
Infertility |
Drug: DR-2011 Drug: Crinone 8% |
Phase III |
| MedlinePlus related topics: | Infertility |
| ChemIDplus related topics: | Progesterone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 1300 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: DR-2011
Progesterone vaginal ring for approximately 10 weeks
|
| 2: Active Comparator |
Drug: Crinone 8%
progesterone vaginal gel for approximately 10 weeks
|
Eligibility
| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 28 Study Locations |
| Duramed Research |
| Study Chair: | Duramed Research Protocol Chair | Duramed Research, Inc. |
More Information
| Responsible Party: | Duramed Rearch, Inc. ( Duramed Research, Inc. ) |
| Study ID Numbers: | DR-PGN-302 |
| First Received: | February 4, 2008 |
| Last Updated: | May 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00615251 |
| Health Authority: | United States: Food and Drug Administration |
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