The pharmacokinetic profile of AG200-15, a low-dose estrogen (EE) and levonorgestrel(Drug information on levonorgestrel) (LNG) contraceptive patch is equivalent whether applied to the abdomen, buttock, or upper torso according to an open-label, three-period randomized crossover study. Exposure is well within reported ranges for low-dose, combined oral contraceptives.
In the study, 24 women applied the patch in random sequence to three anatomical sites and wore the patch on the site for seven days; there was a seven-day washout before the patch was applied to the next anatomical location. Twenty-two women completed the three-cycle trial.
Blood samples were collected before application and at time points up to 240 hours after patch application. Plasma concentrations of LNG and EE were determined by liquid chromatography-mass spectrometry.
The buttock and upper torso sites showed slightly higher LNG and EE exposures versus the lower abdomen. Lead Use of the AG200-15 contraceptive patch yielded LNG and EE exposures well within ranges reported for low-dose, combined oral contraceptives.
Ninety-eight percent of adverse effects were mild, and there were no discontinuations due to adverse effects.
Lead author Frank Stanczyk, PhD, of the University of Southern California, Los Angeles, presented results at the American Congress of Obstetricians and Gynecologists’ Annual Clinical Meeting. “The patch is convenient and causes little irritation,” Stanczyk said. “It can be used on any [of the three] anatomical site[s]; they are all clinically equivalent.” He said some women like to be in control of their contraceptive, and feel more comfortable applying the patch without having to see a physician.