Once-a-month oral contraceptive pill in development

Grant Boone
December 5, 2019

The Pill is still one of the most common forms of contraception, but it only works if you do not forget to take it every single day.

"The problem with the daily pill is it's very effective if taken daily", she said, and it isn't as effective if not taken regularly. The needles biodegrade over time, slowly releasing the contraceptive into the blood.

The centerpiece is a tiny star-shaped device that is placed in a gelatin-coated capsule so it can be swallowed.

The creation of a monthly birth control pill would help to increase the effectiveness of the contraceptive, researchers said.

"We are hopeful that this work - the first example ever of a month-long pill or capsule to our knowledge - will someday lead to potentially new modalities and options for women's health as well as other indications", says Robert Langer, corresponding author of the study. Once in the stomach, the capsule dissolves to reveal the device, whose "arms" expand so that it's too big to pass into the small intestine. Once in the stomach, the arms unfold and have a span that is larger than the opening of the human pylorus, helping the system stay in the stomach where it can release the drug over time. But for the contraceptive pill, the team had to find and test polymers that would not be quickly degraded by stomach acids.

"Certainly one of the theoretical benefits of this drug-delivery system is that it could maximize the efficacy of [birth control pills], because it doesn't depend on daily use", said senior researcher Dr. Giovanni Traverso, from Massachusetts Institute of Technology and Brigham and Women's Hospital in Boston. They made it stronger and turned to long-lasting contraceptive implants for the materials to hold the hormone ingredient and let it gradually seep out. In the United States, around 12.6% of women use an oral contraceptive pill, according to the Centers for Disease Control and Prevention (CDC).

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After testing a number of polymers in simulated gastric fluid, they found that a type of polymer called polyurethane worked the best for the starfish arms and core. The concentration of the drug found in the pigs' bloodstream was similar to the amount that would be present after ingesting daily levonorgestrel tablets.

After the month is up, the star-shaped system breaks apart at the links holding together the arms to the base and exits the body through the digestive tract. The researchers are working on ways to trigger the device arms to snap off - via changes in pH or temperature, for instance.

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.

Langer and Traverso also noted some people might opt for the extended-release pill instead of more invasive options like intrauterine devices, which need to be inserted at the doctor's office.

"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". In July, the startup received $ 13 million from the Gates Foundation to advance the monthly pill to human trials, with a focus on taking it to low and middle income countries.

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