Acrux Announces Results of Combination Contraceptive Spray Phase I Trial

Australian drug company Acrux announced results from its Phase I clinical studies using two unique contraceptive skin sprays.

The first study was a Phase I, pharmacokinetic study, investigating the delivery of a formulation combining Nestorone and the synthetic estrogen, Ethinyl Estradiol, Acrux said.

Single doses of the combination formulation were applied to the forearms of healthy volunteers. The results showed that the dosing of the contraceptive spray provided effective delivery of both contraceptive agents, with blood concentrations of Nestorone and Ethinyl Estradiol in the target range, the company said. The spray was well tolerated, with no serious adverse events recorded, it added.

The second study was a Phase I, pharmacokinetic study, investigating the delivery of a formulation combining Nestorone and the natural estrogen, Estradiol. Single doses of the combination formulation were applied to the forearms of healthy volunteers. The results showed that the dosing of the contraceptive spray provided effective delivery of Nestorone, with blood concentrations in the target range, the company said. The spray was well-tolerated, with no serious adverse events recorded, it added.

Analysis of blood concentrations of Estradiol was inconclusive, due to interaction with background levels of Estradiol in the study population, Acrux said.