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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR-2011 | Drug | Progesterone vaginal ring for approximately 10 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Adverse events | Duration of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duramed Research Protocol Chair | Duramed Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Tarzana | California | 91356 | United States | ||
| Duramed Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30396554 | Derived | 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. | |
| 23465817 | Derived |
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| Crinone 8% |
| Drug |
progesterone vaginal gel for approximately 10 weeks |
|
| West Los Angeles |
| California |
| 90064 |
| United States |
| Duramed Investigational Site | Westlake | California | 91361 | United States |
| Duramed Investigational Site | Clearwater | Florida | 33759 | United States |
| Duramed Investigational Site | Alpharetta | Georgia | 30005 | United States |
| Duramed Investigational Site | Atlanta | Georgia | 30342 | United States |
| Duramed Investigational Site | Boise | Idaho | 83702 | United States |
| Duramed Investigational Site | Chicago | Illinois | 60610 | United States |
| Duramed Investigational Site | Highland Park | Illinois | 60035 | United States |
| Duramed Investigational Site | Rockville | Maryland | 20850 | United States |
| Duramed Investigational Site | Dearborn | Michigan | 48126 | United States |
| Duramed Investigational Site | Flint | Michigan | 48503 | United States |
| Duramed Investigational Site | Rochester Hills | Michigan | 48307 | United States |
| Duramed Investigational Site | Saginaw | Michigan | 48604 | United States |
| Duramed Investigational Site | Ypsilanti | Michigan | 48197 | United States |
| Duramed Investigational Site | Woodbury | Minnesota | 55125 | United States |
| Duramed Investigational Site | Reno | Nevada | 89511 | United States |
| Duramed Investigational Site | Marlton | New Jersey | 08053 | United States |
| Duramed Investigational Site | Morristown | New Jersey | 07960 | United States |
| Duramed Investigational Site | Cincinnati | Ohio | 45209 | United States |
| Duramed Investigational Site | Sylvania | Ohio | 43560 | United States |
| Duramed Investigational Site | Columbia | South Carolina | 29201 | United States |
| Duramed Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Duramed Investigational Site | Myrtle Beach | South Carolina | 29577 | United States |
| Duramed Investigational Site | Austin | Texas | 78731 | United States |
| Duramed Investigational Site | Beaumont | Texas | 77706 | United States |
| Duramed Investigational Site | Bedford | Texas | 76022 | United States |
| Duramed Investigational Site | Webster | Texas | 77598 | United States |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | United States |
| 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. |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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