USA scientists test first monthly contraceptive pill in pigs

The study found that women taking the pill, or oral contraceptives, had a smaller hypothalamus than women not taking the pill.

Women who use birth control pills have a significantly smaller hypothalamus volume, a region of the brain associated with anger and depression, than those who do not take oral contraceptive pills (OCPs), according to preliminary findings presented at the Radiological Society of North America (RSNA).

The trick: A tiny star-shaped gadget that unfolds in the stomach and gradually releases the drug.

The pill, which so far has only been tested in pigs, uses a new star-shaped drug delivery system that stays in the digestive tract for days or weeks after being swallowed, researchers from Harvard's Brigham and Women's Hospital and the Massachusetts Institute of Technology reported in the journal Science Translational Medicine. That would alert women when it was time to take another monthly dose. But for the contraceptive pill, the team had to find and test polymers that would not be quickly degraded by stomach acids. The researchers tested materials by soaking them in simulated gastric fluid, which is very acidic, and found that two types of polyurethane worked best for the arms and the central core of the star. Once the capsule reaches the stomach it expands and becomes lodged in place. However, the capsules maintained these drug levels for almost a month, while the tablets last for only a day.

Then they tested the contraceptive capsules in pigs, which have human-like digestive systems. The researchers are working on several possible ways to trigger the arms to break off, including through changes in pH, changes in temperature, or exposure to certain chemicals.

"It has a lot of potential", said Dr. Beatrice Chen, a family planning specialist at the University of Pittsburgh, who wasn't involved in the new research. When the team looked at overall brain region volume, the hypothalami in women on birth control were about 6 percent smaller than those of other women.

Lyndra Therapeutics Inc., a MA company co-founded by Langer and Traverso, is further developing the monthly pill and multiple other uses for the technology.

"Through the development of these technologies, we aim to transform people's experience with taking medications by making it easier, with more infrequent dosing in the first once-a-month, orally delivered drug system".

At this point, the drug is still highly experimental, and the researchers caution that it could be 3 to 5 years before it is tested in humans.

To be most useful, the capsule should be created to emit three weeks of contraception and then allow for a woman's period, like a month's supply of birth control pills does, Traverso said. "Assuming this finding is a true finding, what does it mean for a woman whose hypothalamus is made smaller by oral contraceptives?"

"Coming up with a monthly version of a contraceptive drug could have a tremendous impact on global health", Kirtane says.

Oral contraceptives are among the most popular forms of birth control and are also used to treat a host of conditions, including irregular menstruation, cramps, acne, endometriosis and polycystic ovary syndrome.

Today, women who want the convenience of long-lasting contraception can choose among various devices, from a weekly patch to a monthly vaginal ring to an IUD that lasts for years.

"We found a dramatic difference in the size of the brain structures between women who were taking oral contraceptives and those who were not", Dr. Lipton said. "For those patients, something like this would be extremely helpful". Other MIT authors of the study are Alison Hayward, Aniket Wahane, Aaron Lopes, Taylor Bensel, Sierra Brooks, Declan Gwynne, Jacob Wainer, Joy Collins, and Siid Tamang.

/University Release. View in full here.

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