Ethinyl Estradiol

HELSINKI, May 20, 2025 /PRNewswire/ -- New research presented today at the European Stroke Organisation Conference (ESOC) 2025 revealed that the use of combined oral contraceptives (OCs) is associated with a threefold increase in the risk of cryptogenic ischaemic stroke (CIS) in young women.(1) The findings add to a growing body of evidence linking hormonal contraception to vascular risk in women of reproductive age. Cryptogenic ischaemic stroke, which is stroke with no identifiable cause, accounts for up to 40% of all ischaemic strokes in young adults.(2) Despite its prevalence, the contribution of sex-specific risk factors, such as contraceptive use, has remained underexplored. While prior studies have associated combined OCs with stroke risk, this is among the few studies to focus specifically on cryptogenic stroke in young women. The Searching for Explanations for Cryptogenic Stroke in the Young (SECRETO) study included 268 women aged 18–49 years with CIS and 268 age-matched stroke-free controls across 14 centres in Europe. Of the participants, 66 patients and 38 controls were using combined OCs. After adjusting for age and established comorbidities such as hypertension, smoking, migraine with aura, and abdominal obesity, OC use was associated with an adjusted odds ratio of 3.00 (95% CI: 1.61–5.57). No significant interactions were found between OC use and these risk factors, suggesting that the increased stroke risk may operate independently of other known contributors. "Our findings confirm earlier evidence linking oral contraceptives to stroke risk," said Dr. Mine Sezgin, Department of Neurology, Istanbul University, and lead author of the study. "What's particularly notable is that the association remains strong even when accounting for other known risk factors, which suggests there may be additional mechanisms involved – possibly genetic or biological." Most OC users in the study were taking ethinylestradiol-based formulations, with a median dose of 20 micrograms. Other types of estrogen, such as estradiol hemihydrate and estradiol valerate, were also recorded. "We calculated the equivalent estrogen dose for each patient to ensure consistency," Dr Sezgin explained. "While our data provides important initial insights, larger studies are needed to determine if certain formulations carry different levels of risk. This knowledge could help guide more personalised contraceptive choices for women." While the researchers note that further prospective studies are needed, they advise clinicians to exercise caution when prescribing combined OCs to women with known vascular risk factors or a history of ischaemic stroke. "Our findings should prompt more careful evaluation of stroke risk in young women, particularly those with additional risk factors," concluded Dr. Sezgin. Moving forward, the researchers plan to explore biological and genetic mechanisms underlying the observed association between combined OC use and increased stroke risk to better understand how hormonal contraceptives may independently elevate stroke risk. Note to editors: A reference to ESOC 2025 must be included in all coverage and/or articles associated with this study. About the study author: Dr. Mine Sezgin is a neurologist and stroke researcher based at the Istanbul University Faculty of Medicine. Her work focuses on sex-specific risk factors and stroke prevention in young adults. About the European Stroke Organisation (ESO): The ESO is a pan-European society of stroke researchers and physicians, national and regional stroke societies and lay organisations that was founded in December 2007. The aim of the ESO is to reduce the burden of stroke by changing the way that stroke is viewed and treated. This can only be achieved by professional and public education, and by making institutional changes. ESO serves as the voice of stroke in Europe, harmonising stroke management across the whole of Europe and taking action to reduce the burden of stroke regionally and globally. References: 1. Sezgin, M., et al. Hormonal contraception increases the risk of cryptogenic stroke in young women. Abstract O049, presented at the European Stroke Organisation Conference; 21 May 2025; Vienna, Austria. 2. Yaghi, S., & Elkind, M. S. (2014). Cryptogenic stroke: A diagnostic challenge. Neurology. Clinical practice, 4(5), 386–393. SOURCE European Stroke Organisation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The FDA sent the untitled letter on April 28 and gave Mayne 15 working days to respond. Mayne Pharma is in trouble with the FDA. The agency has accused the Australian pharma of giving a misleading impression of the risks of its oral birth control pill in a presentation, triggering an untitled letter (PDF).FDA officials sent the letter after reviewing a slide deck (PDF) about Mayne’s contraceptive medication Nextstellis. The FDA claimed the presentation minimized the risks associated with Nextstellis and misrepresented how the drug compares to rival estrogen-containing combined hormonal contraceptives. Those failings are particularly concerning, according to the agency, because Nextstellis is linked to potentially life-threatening risks. The FDA said the deck contains “misleading” claims that estetrol, one of the active ingredients in Nextstellis, is unique and intrinsically different from other estrogens. For example, claims that estetrol is “low impact” and has “minimal effect on the liver” suggest Nextstellis is safer than other estrogen-containing oral contraceptives, the FDA said, but that has “not been demonstrated.”Sections of the deck deal specifically with the effect of Nextstellis on breast and liver tissue. One slide compares the “slow, extensive” hepatic metabolism of ethinyl estradiol, another estrogen commonly used in birth control pills, to the “minimal” hepatic metabolism of estetrol. The FDA said the slide misleadingly suggests estetrol has safety advantages over ethinyl estradiol.Other slides say estetrol has “a low impact on breast tissue” and “does not stimulate breast tissue.” The FDA said the slides add to the misleading impression about the comparative safety of Nextstellis and rival oral contraceptives.“These claims suggest that Nextstellis is a safer option for patients who have or have had breast cancer when, in fact, Nextstellis is contraindicated in patients with a current diagnosis or history of breast cancer, which may be sensitive to female hormones,” the FDA said. The FDA sent the untitled letter on April 28 and gave Mayne 15 working days to respond in writing. Mayne did not immediately respond to Fierce Pharma Marketing’s request for comment.Nextstellis has been approved in the U.S. since 2021, when its estetrol became the first new estrogen introduced in the country in over half a century, per the company. Just a week before the FDA sent the letter, in an April 22 business update, Mayne reported (PDF) lower-than-expected volumes of Nextstellis, even as net sales for its overall women’s health segment grew 8% year over year.Cosette Pharmaceuticals agreed to buy Mayne for $430 million in February. Cosette satisfied (PDF) one of the takeover closing conditions last week, keeping it on track to complete the deal in June or July.