Daré Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Contraceptive
The agreement will allow Dar to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.
- The agreement will allow Dar to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.
- The pivotal Phase 3 study will be supported by the NICHDs Contraceptive Development Program (CDP).
- Under the CRADA, Dar has also agreed to contribute $5.5 million toward the total estimated cost to conduct the pivotal Phase 3 study, which will be payable in four payments.
- The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability.