Low-dose Contraceptive Patch Works

Birth control patch shows promise

(RxWiki News) Finding the right type of birth control can be tricky. A new type of contraceptive may be another option for your birth control.

The latest study tested a contraceptive patch that delivers a low dose of combo hormones, and found that it works just as well as combined oral contraceptives.

Ask you doctor if a birth control patch is right for you.

Researchers from the University of Florida, Eastern Virginia Medical School and other universities looked at more than 1,500 women from diverse backgrounds that included minorities, obese women and new users of oral contraceptives.

Half of the women used a once-weekly low-dose combination contraceptive patch containing ethinyl estradiol and levonorgestrel, also known as AG200-15 or the “Agile Patch.” The other half of the group received low-dose oral contraceptives. The patch was applied for three weeks, followed by a fourth week in which the patch was not worn.

The research team reports that the contraceptive patch was as effective as oral contraceptives.

The study measured the effectiveness of the drug with the Pearl Index, which is often used in clinical trials. They report that the women using the combo patch drug had a Pearl score of 4.96, compared to 4.02 for women on combined oral contraceptives, which is not a significant difference, says principal investigator Dr. Andrew Kaunitz, associate chair and professor of the department of obstetrics and gynecology at the University of Florida.

The study was conducted over a wide spectrum of reproductive-age women, unlike in other clinical trials, says Kaunitz.

The combo patch delivered the equivalent to 30 ug of ethinyl estradiol. The combined oral contraceptive pills delivered 20 ug of ethinyl estradiol and 0.1 mg levonorgestrel.

This year-long trial was the third phase of testing for the contraceptive patch.

The mean age of the study subjects was 26.4 years. In both groups, about half of the women were white/non-Hispanic. A majority of the women (60%) were new users of hormonal contraceptives. Less than 30% of the women in the two groups smoked (27% and 29%).

The study found that obese women had lower scores and, thus, a lower chance of getting pregnant:

Obese women with a BMI greater than 32 kg had a score of 2.85, while women with a lower BMI had a score of 3.17.

One other study of the drug shows that the patch can be worn on one of three body parts – abdomen, buttock or upper torso – and that the amount of active ingredients in blood levels will remain the same.

A third study found that the patch adheres to the skin and maintains no difference in blood levels under various conditions, including in a whirlpool tub, sauna and during vigorous exercise.

Both of these studies were presented by Dr. David F. Archer, professor of obstetrics and gynecology at Eastern Virginia Medical School.

“Our results show the patch will stay in place and continue to deliver hormones under a variety of external conditions,” Archer says in a press release. It provides women a birth control option that fits in with daily activities, he says.

According to the researchers, the women experienced side effects that included abnormal changes in cervix cells (cervical dysplasia), common cold (nasopharyngitis), nausea, upper respiratory infection, sinusitis, headache, urinary tract infection, human papilloma infection, breast tenderness, weight gain and vaginal infection.

Agile Therapeutics, the company that manufactures the combined contraceptive, submitted an application for the drug to the Food and Drug Administration.

This study was sponsored by Agile Therapeutics and presented at the American College of Obstetricians and Gynecologists’ 60th Annual Clinical Meeting in San Diego. 

Review Date: 
May 14, 2012