Study Questions Safety of Progestins in Contraception

A study presented to the Temporary Scientific Committee of the French Medicines Agency (ANSM) evaluated the risk for meningioma in women using levonorgestrel or desogestrel in oral contraception and found a slight increase in the risk with prolonged use of desogestrel-based contraception in women aged > 45 years. These two progestins are widely used in France. 

Conducted by the EPI-PHARE scientific group, formed by ANSM and the French National Health Fund, this study aligns with previous research that identified a risk for meningiomas associated with certain progestins, including Androcur (cyproterone acetate), Lutéran (chlormadinone acetate), Lutényl (nomegestrol), Depo-Provera (medroxyprogesterone acetate), Colprone (medrogestone), and Sugestone (promegestone).

The case-control study analyzed data from 8391 women who underwent surgery for intracranial meningiomas between 2020 and 2023, using data from the National Health Data System. It assessed the risk for intracranial meningioma using reimbursed contraceptive progestins, namely desogestrel (75 µg), levonorgestrel (30 µg), and a levonorgestrel-ethinylestradiol combination (50-150 µg).

The study found that the use of levonorgestrel, either alone or in combination with ethinylestradiol, was not associated with an increased risk for intracranial meningioma, regardless of the duration of exposure.

A slightly increased risk for meningioma was observed in women over 45 years old who used 75 µg desogestrel for prolonged periods. This risk emerged after 5 years of use, doubling after 7 years of exposure. No increased risk was found with less than a year of desogestrel use, except for women who had previously used other progestins with known risks.

On average, the study estimated that one case of intracranial meningioma requiring surgery occurs for every 67,000 women exposed to desogestrel, regardless of the duration of exposure, and one case per 17,000 women exposed for more than 5 years. This risk is much lower than that associated with other progestins, such as cyproterone acetate, chlormadinone acetate, and norgestrel.

Recommendations from ANSM

Based on the study’s findings, ANSM experts issued the following preliminary recommendations for physicians and midwives:

• MRI screening is recommended for patients using desogestrel who show signs suggestive of meningioma. 
• If a meningioma is detected in a patient using desogestrel, discontinue the treatment and refer the patient to a neurosurgeon. In cases of a previous meningioma or an existing meningioma, progestin-based contraception or treatment should no longer be used. 
• Before prescribing or changing progestin-based contraception, physicians should review the patient’s previous progestin treatments and their duration. Collaborate with the patient to determine the most suitable contraception based on this information. 
• Contraception should be reviewed annually, considering factors such as age, lifestyle, and medical history. 
• Desogestrel is approved exclusively for contraception and should not be used for hormone replacement therapy in menopause. 

This story was translated, with slight adaptation, from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.