Acrux, a Melbourne, Australia-based drug-delivery specialist, has reported positive results from Phase I clinical studies using two unique contraceptive skin sprays, each containing a progestin and an estrogen.
The first Phase I, pharmacokinetic study, investigated the delivery of a formulation combining Nestorone and the synthetic estrogen, ethinyl estradiol. A single dose of the combination was applied to the forearm of healthy volunteers. The results showed that the dosing of the contraceptive spray provided effective delivery of both agents, with blood concentrations of both compounds in the range expected to provide effective contraception. The spray was well tolerated, with no serious adverse events recorded, Acrux noted.
The second Phase I, pharmacokinetic study, investigated the delivery of a formulation combining Nestorone and the natural estrogen, estradiol. A single dose of the combination formulation was applied to the forearm 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 that is expected to provide effective contraception.
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