Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00615251 | A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization | PHASE3 | COMPLETED | 1,297 | — | — | Feb 1, 2008 | Aug 1, 2009 | Sep 13, 2013 | 29 | United States |
| NCT00117468 | Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement | PHASE2 | COMPLETED | 20 | — | — | Jun 1, 2005 | Apr 1, 2006 | May 12, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DR-2011 | DRUG | Progesterone vaginal ring for approximately 10 weeks |
| Crinone 8% | DRUG | progesterone vaginal gel for approximately 10 weeks |
| Progesterone 8% Vaginal Gel | DRUG | Administered vaginally from Cycle Day 14 to Day 31 |
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 use...