This next year of work will build on the contraceptive efficacy shown in the rabbit model where we showed 100% protection in the treated animals that received 0.7 mL of gel at pH 4.8 and 200 mg/mL. We are concerned that increasing the concentration of the gel will make this system too costly. We will increase the molecular weight of polymers we use in the next round of studies in the rabbit model so that we can reduce the overall polymer concentration. Next, we are planning to test the duration of contraceptive protection after SMP application l. In the previous studies rabbit semen was administered 15 min after gel application. We will study the duration of the contraceptive effect by measuring efficacy of the gel after 12 hours, 1, 2 and 3 days of gel application. Minimum volume of gels needed to provide protection will also be investigated by reducing the volume of SMP gel applied until the protection effect is decreased. Finally since we are using this model extensively we will conduct a month long repeat dose safety study of gels made from high molecular weight polymers where we administer the gel 10 times over 20 days and conduct immunohistochemistry and histological pathology on the rabbit vaginal tract. We will also publish the results from our work.
|Effective start/end date||1/1/14 → 6/30/15|
- Bill & Melinda Gates Foundation (OPP1035203)