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Ozempic and similar GLP-1 drugs have become widely known for their powerful weight loss effects and are now proven effective in treating many other chronic diseases.
Women are also finding other benefits that drug companies may not be aware of. Unplanned pregnancy Researchers believe that fertility and hormonal disorders may also be affected among women receiving GLP-1 treatment.
Pediatric endocrinologist Melanie Cree of Children’s Hospital Colorado is one of the doctors investigating the issue. Working with her colleagues, she Randomized trials Semaglutide, a component of Novo Nordisk’s Rybelsus and Wegovy, will be tested in women and adolescents with polycystic ovary syndrome (PCOS).
Currie said the study “provides evidence of what specific effects these drugs may have on PCOS, fertility and menstruation.” The results of Currie’s first trial have yet to be published, but they’re encouraging enough to spur Currie on. Launching another, larger trial To test the relationship between weight loss, metabolic changes, and reproductive function in patients with PCOS.
PCOS is a set of symptoms caused by a hormonal imbalance, usually the overproduction of testosterone, that prevents ovulation. The condition causes cysts to develop in the ovaries, which in turn alters an individual’s menstrual cycle and can lead to infertility. People with PCOS: Insulin resistancewhich increases the risk of type 2 diabetes and other cardiometabolic problems. The disorder is usually diagnosed during adolescence.
There is no standard treatment for PCOS, and the diagnosis is often it takes time And it’s difficult. World Health Organization estimates Worldwide, 70% of affected women remain undiagnosed.
“(Researchers) have yet to identify the cause or underlying etiology of the disease,” said Pardis Hosseinzadeh, M.D., assistant professor of obstetrics and gynecology at the Johns Hopkins University School of Medicine. “So while we don’t yet fully understand that, it makes it difficult to treat PCOS, because it affects so many different organ systems in the body.”
Depending on your symptoms, your doctor may recommend a variety of medications and other interventions, such as weight management and birth control to help ease ovulation, mood changes, and hormonal acne.
“Studies like mine and my colleagues’ work are extremely important because there are currently no FDA-approved medications for PCOS,” Cree said.
Weight loss Improves symptoms of PCOS Therefore, it is usually the aim of treatment. MetforminAlthough it is a diabetes treatment, it is not recommended for use with other lifestyle interventions or Bariatric surgery can also be used.
“One of the main reasons I started looking into GLP-1 is because there’s such a strong connection between weight, PCOS hormones, and PCOS physiology,” Cree says.
Endocrinologists and other doctors who treat women with PCOS are well aware of how weight loss can affect menstrual cycles and hormone regulation. Last year, the American Society for Reproductive Medicine (ASRM) said: Treatment Guidelines for PCOSThis had not changed since 2018. The new guidelines note that GLP-1 drugs such as semaglutide may be useful for weight management.
Chau Tien Tay, an endocrinologist at Monash Health who helped write the new guidelines, told BioPharma Dive that weight loss therapies were considered in the previous framework. The addition of GLP-1 “simply reflects a changing treatment landscape, driven by recent advances and clinical evidence,” he wrote.
In her new research, Cree aims to explore whether weight loss, regardless of method, can ease PCOS symptoms, or whether GLP-1 drugs specifically could help with hormonal disorders.
of 10 month trialwill recruit 80 girls and women aged 12 to 35 to test the effect of injected semaglutide on ovulation, and will also assess whether age and metabolic and hormonal changes can predict response to GLP-1 treatment.
“By looking across the entire reproductive lifespan, (this study) will help us understand whether there are differences in how teenagers and adults respond and help us determine and move towards personalized medical care,” Cree said.
The previous Small study using oral semaglutide In the shorter term, Cree thinks the injectable version could help regulate ovulation.
“Many patients with PCOS, or those who suffer from PCOS and other issues like insulin resistance or obesity, may experience irregular periods because of irregular ovulation,” Hosseinzadeh says. “It’s well known (among health professionals) that for those with PCOS, losing up to 5% of their body weight can help regularize ovulation and regulate their periods.”
The expected benefits of GLP-1 drugs for PCOS may be linked to their impact on fertility, and researchers are currently investigating this effect in more detail. Widespread coverage on social media.
There is thought to be an association between weight loss and fertility and pregnancy outcomes, but the strength of this association remains unclear. Unclear.
Some doctors speculate that unexpected pregnancies in people taking GLP-1 may be due to the drug’s ability to slow the digestive process, affecting the effectiveness of oral contraceptives.
Wegovy, which contains semaglutide and is labelled as an obesity treatment, comes with a warning to stop using it. 2 months ago For women planning pregnancy, the ASRM PCOS guidelines recommend contraception for women taking GLP-1. limited safety data During pregnancy.
A Novo Nordisk spokesman said in an email that based on animal studies, Wegovy may pose a risk to the fetus during pregnancy. registry For Wegovy to collect safety information.
The spokesperson added that Novo “has not conducted, and has no immediate plans to conduct, studies to evaluate the efficacy and safety of FDA-approved GLP-1 drugs in women with PCOS.”
An Eli Lilly spokesperson said the company “has not studied tirzepatide’s effects on human fertility.” (Tirzepatide is an ingredient in Zepbound, an obesity drug sold by Lilly.) Lilly is urging pregnant women who have been exposed to Zepbound to contact the company. The spokesperson did not respond to BioPharma Dive’s questions about PCOS.
The company’s position is not unusual. Pregnant women, danger It could potentially harm the fetus, and the dramatic weight loss induced by GLP-1 treatment may not be good for your health during pregnancy.
“I think it’s too early to say that[weight-loss drugs]can be used for other indications or that they’re completely safe to use before or in patients who are trying to become pregnant,” Hosseinzadeh said, “so we still need a bit more data, but we also don’t have the data to say that they’re harmful.”
Such information is important because GLP-1 drugs have proven particularly appealing to women. similarRecent US data shows that prescriptions for weight-loss drugs like Ozempic are disproportionately given to women. Quoted by ReutersAccording to previous data from pharmacy benefit management company Prime Therapeutics. Similar imbalancesClinical Trial Testing Wegovi and Zepbound More women than men enrolled due to obesity.
“GLP-1 may be able to help women with PCOS in the long term,” Hosseinzadeh said. “We tend to focus so much on fertility and the effects on reproduction during the reproductive years, but we’re looking at the middle part of the spectrum — a condition that affects women throughout their lives.”