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DR-2011 · 2 trials · 1 indication
| 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...
DR-2011 is an investigational small molecule developed for infertility. It has been studied in women undergoing in vitro fertilization and in luteal phase replacement, where it was compared with a progesterone vaginal gel. Both clinical trials enrolled women aged 18 years and older in the United States.
DR-2011 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored both of the clinical trials listed for this asset, one Phase 3 study in in vitro fertilization and one Phase 2 study in luteal phase replacement.
DR-2011 has completed a Phase 3 trial and a Phase 2 trial, and it is not currently listed as approved. The Phase 3 study evaluated efficacy and safety in in vitro fertilization, while the Phase 2 study compared DR-2011 with a progesterone vaginal gel for luteal phase replacement.
Two completed trials are registered for DR-2011. NCT00615251 was a Phase 3 trial of DR-2011 for in vitro fertilization that enrolled 1,297 women. NCT00117468 was a Phase 2 trial comparing DR-2011 with a progesterone vaginal gel for luteal phase replacement that enrolled 20 women.
The two completed DR-2011 trials enrolled a combined total of 1,317 participants. The Phase 3 in vitro fertilization study, NCT00615251, accounted for 1,297 of those participants, and the Phase 2 luteal phase replacement study, NCT00117468, enrolled 20 participants.
Yes. Both DR-2011 trials were randomized and used an active control design. The Phase 3 in vitro fertilization trial, NCT00615251, and the Phase 2 luteal phase replacement trial, NCT00117468, were active controlled, and both studies were completed. Neither trial used a double blind design.