Menopause Research 2025

The U.S. Food and Drug Administration (FDA) has expanded its approval of the daily libido-boosting pill Addyi (flibanserin) to include postmenopausal women up to age 65 who experience distress due to low sexual desire. Originally approved in 2015 for premenopausal women with hypoactive sexual desire disorder (HSDD), this FDA menopause approval now extends to offer new postmenopausal treatments, providing a fresh option for women navigating midlife changes in sexual desire. 

Addyi works differently from traditional hormone therapy; it acts on neurotransmitters in the brain to help regulate mood and sexual desire instead of replacing hormones. While it may assist some women who have experienced a decline in libido associated with age and menopause, medical experts highlight that HSDD is a complex condition influenced by various factors—physical, emotional, and relational. Hence, menopause awareness emphasizes that treatment may yield the best results when combined with broader approaches to health and communication.

The pill carries important safety considerations, including a boxed warning regarding the risk of dangerously low blood pressure and fainting when combined with alcohol, thus patients should adhere to guidance and consult their healthcare providers closely. 

This approval is another step forward in recognizing women's sexual well-being at different life stages and broadening options for those addressing the challenges of postmenopausal desire. This summary, posted December 19, 2025, is based on reporting by Matthew Perrone for The Associated Press, originally published December 15, 2025.

A new CNN report reveals that worldwide awareness about menopause remains worryingly low, and that this lack of knowledge can have serious consequences. According to the article, many women globally experience menopause with little to no prior information about what’s happening, leaving them unprepared for common symptoms such as hot flashes, night sweats, mood changes, sleep disturbances, vaginal and urinary issues, and long-term health risks. Experts in the report emphasize that the limited awareness not only among women but also within healthcare systems contributes to misdiagnosis, untreated symptoms, and overlooked risks like heart disease, osteoporosis, and mental health conditions. The article highlights the need for improved menopause awareness, better training for clinicians, and more inclusive global health policies that treat menopause as a critical phase of women’s health rather than a taboo topic. Furthermore, with recent FDA menopause approvals and updates on hormone therapy, it is vital that menopause research continues to inform postmenopausal treatments. This summary (posted December 4, 2025) is based on reporting by Sashikala VP for CNN World, originally published December 4, 2025.

On November 10, 2025, the FDA released a fact sheet detailing important hormone therapy updates, including plans to revise the labeling of estradiol hormone therapy products. The agency is advocating for pharmaceutical companies to eliminate references to cardiovascular disease, breast cancer, and probable dementia from the black box warning, which highlights the most serious potential risks of these products.

However, the black box warning for endometrial cancer will remain for systemic estrogen-only products. This is crucial since estrogen-only therapy, when not balanced with progesterone in women who still have a uterus, can heighten the risk of endometrial cancer. The FDA continues to emphasize this risk to promote safe prescribing practices.

Additionally, the FDA recommends that systemic hormone therapy (HRT), a key aspect of postmenopausal treatments, be initiated within 10 years of menopause onset or before age 60. This guideline is based on a review of current scientific evidence, including menopause research that revisits data from younger women in the Women’s Health Initiative (WHI) and related studies.

Hormone therapy, also referred to as menopausal hormone therapy (MHT) or hormone replacement therapy (HRT), is approved to alleviate common menopause symptoms such as hot flashes, night sweats, and changes in vaginal or urinary functions due to estrogen loss. Certain products are also recognized for their role in the prevention of osteoporosis.

Evidence indicates that beginning HRT within 10 years of menopause onset may provide significant benefits for most women, such as a reduced risk of all-cause mortality, fractures, heart attacks (by up to 50%), cognitive decline (by 64%), and Alzheimer’s disease (by 35%).

A pooled analysis of 30 trials involving 26,708 women found no increased cancer mortality associated with HRT. Furthermore, women who start therapy before age 60 seem to face a lower overall mortality risk.

This summary (posted November 10, 2025) reflects an HHS Press Release – FDA Initiates Removal of Black Box Warnings from Menopausal Hormone Therapy Products, released on the same date.

A new Mayo Clinic study underscores the widespread impact of menopause symptoms on midlife women and the concerning reality that most are navigating this stage without adequate medical support. Surveying nearly 5,000 women aged 45–60, researchers found that over 75% experienced symptoms affecting their daily life, yet more than 80% had not sought care. This highlights the urgent need for increased menopause awareness and access to postmenopausal treatments. 

Common issues such as sleep disturbances and weight gain were reported by over half of the participants, with one-third facing moderate to severe symptoms. Despite recent FDA menopause approvals and hormone therapy updates demonstrating effective treatments, only 1 in 4 women received any form of care. 

Lead author Dr. Ekta Kapoor emphasizes the importance of more proactive strategies to bridge this treatment gap, including tools to help women identify symptoms and engage in meaningful conversations with healthcare providers. The findings highlight the necessity to destigmatize menopause care and enhance support access, reflecting ongoing menopause research efforts. 

This summary (posted November 4, 2025) is based on reporting by Sharon Theimer for Mayo Clinic, originally published October 29, 2025.

The U.S. FDA has granted approvals for Lynkuet (elinzanetant), Bayer’s innovative oral non-hormonal therapy designed to alleviate moderate to severe hot flashes (vasomotor symptoms) associated with menopause. This marks a significant advancement in hormone therapy updates, following its prior authorization in the U.K. and recent approvals in countries like Australia, Canada, and Switzerland, with additional reviews for FDA menopause approvals ongoing in other regions.

In two placebo-controlled studies involving 796 menopausal women, Lynkuet demonstrated a notable reduction in both the frequency and severity of hot flashes at 4 and 12 weeks. This once-daily soft gel capsule, taken before bedtime, effectively targets the NK1 and NK3 receptors in the brain, pathways crucial for regulating body temperature.

Bayer anticipates the U.S. launch of Lynkuet in November 2025, further enhancing menopause awareness and providing an important option among postmenopausal treatments.

As with any medication, safety considerations are paramount. Serious side effects may include excessive sleepiness, dizziness or fainting, liver test abnormalities, pregnancy loss, and an increased risk of seizures in individuals with a seizure history. Common side effects include headache, fatigue, stomach pain, rash, diarrhea, and muscle spasms.

Lynkuet presents a valuable non-hormonal alternative for managing hot flashes, serving as a complementary option to Astellas Pharma's Veozah (fezolinetant), which specifically targets only NK3 receptors.

This summary, dated October 27, 2025, is based on a press release issued by Bayer on October 24, 2025.

New findings from researchers at Ponce Health Sciences University’s BRAVE Lab are shedding light on how menopause can affect brain function and feelings, contributing to menopause awareness and ongoing menopause research. Brain scans reveal that menopause may lead to changes in brain structure, particularly in regions responsible for memory, language, and spatial skills. During this period, key areas like the frontal, temporal, and hippocampal regions may shrink, potentially explaining common symptoms such as forgetfulness or brain fog, echoing discussions seen in recent FDA menopause approvals and hormone therapy updates. 

Interestingly, scientists also discovered an increase in estrogen receptors during menopause, suggesting the brain’s way of adapting to lower hormone levels. This adaptation may play a role in temporary cognitive changes experienced by many. 

Additionally, changes in blood flow and energy utilization may further influence how effectively the brain functions and manages stress. The encouraging news is that early evidence indicates the brain shows signs of recovery and adaptation after menopause, offering hope that these changes may not be permanent and may guide future postmenopausal treatments. 

This summary (posted October 22, 2025) is based on reporting from Science Daily, originally published October 21, 2025.

New menopause research presented at the 2025 Menopause Society meeting in Orlando revealed that gastrointestinal (GI) problems could be a hidden issue for many women during menopause. As part of ongoing menopause awareness efforts, a study of nearly 600 British women aged 44 to 73 found that many reported digestive issues that began or worsened during this transitional phase. Bloating (77%) and constipation (54%) were the most common complaints, with stomach pain (50%) and acid reflux (49%) following closely behind. Over half of the women experienced these symptoms frequently, and 55% stated that their quality of life was affected significantly.

Lead researcher Nigel Denby, a registered dietitian based in London, emphasized, “Digestive health problems at midlife are often brushed aside, yet our research shows they are both widespread and impactful for women.” In this context, it is essential to consider new FDA menopause approvals and hormone therapy updates that may address such symptoms.

Only one-third of participants had been diagnosed with irritable bowel syndrome (IBS), and while over half sought medical help, most felt they did not receive adequate care, highlighting a gap that calls for further menopause research.

Dr. Stephanie Faubion, medical director of The Menopause Society, noted the importance of recognizing GI problems as part of the menopause experience. She stated, “Symptoms like hot flashes, night sweats, and mood changes are more widely recognized, so it can be easy to overlook or underestimate the significance of digestive issues that may be happening at the same time.” As healthcare providers focus on postmenopausal treatments, understanding the full spectrum of menopause symptoms, including GI problems, is crucial.

This summary (posted October 21, 2025) is based on reporting by Dennis Thompson for HealthDay, originally published October 21, 2025.

FDA Commissioner Dr. Martin Makary recently shared insights with CNN’s Dr. Sanjay Gupta on the Chasing Life podcast, stating, “We are in serious discussions now about what to do about the black box warning, and I think you’ll hear something on it very soon.” 

The FDA is currently reviewing potential updates to the black box warning for certain menopause hormone therapies, a decision that may align with recent menopause research highlighting their benefits and risks. This review is a follow-up to a panel convened by the FDA in July to evaluate evidence from the Women’s Health Initiative (WHI) and to discuss hormone therapy safety. Panelists recommended that the agency consider removing the warning label. 

Support for hormone therapy in alleviating menopausal symptoms has been voiced by four major medical societies: the American College of Obstetricians and Gynecologists, the Menopause Society, the Endocrine Society, and the American Association of Clinical Endocrinology. However, they do not endorse its use for preventing chronic conditions like heart disease. 

While the ongoing discussions and FDA menopause approvals are promising, experts caution that hormone therapy is not a one-size-fits-all solution. It's crucial to consult your healthcare provider and remain vigilant against misinformation online. 

This summary (posted October 9, 2025) is based on reporting by Brenda Goodman, CNN, originally published October 3, 2025.

Cornell’s Ithaca campus and Weill Cornell Medicine are launching Menopause Health Engineering, a new initiative focused on enhancing menopause awareness by investigating how menopause affects women’s health and disease risk, as well as developing improved postmenopausal treatments. Dr. Nozomi Nishimura, an associate professor in the Meinig School, founded the initiative to deepen scientific understanding of menopause.

Addressing longstanding bias in biomedical research and clinical trials that often favor male subjects, the program will examine how menopause influences various diseases associated with aging, aligning with the latest FDA menopause approvals and hormone therapy updates.

This summary (posted October 1, 2025) is based on reporting by Melia Matthews in the Cornell Chronicle, originally published September 29, 2025.

A recent re-analysis of the Women’s Health Initiative (WHI) Study, which involved 27,347 women, highlighted significant findings regarding menopause research. The study revealed that menopausal hormone therapy (MHT) with estrogen (CEE) or CEE plus progesterone (MPA) effectively reduced moderate to severe hot flashes and night sweats, known as vasomotor symptoms (VMS), in women aged 50–59 without significantly increasing the risk of Atherosclerotic Cardiovascular Disease (ASCVD; including serious conditions like heart attack, stroke, and blocked arteries). This aligns with recent FDA menopause approvals for MHT, emphasizing the importance of hormone therapy updates in postmenopausal treatments. 

Key Findings:  

Women 50–59:  

- Greatest relief from vasomotor symptoms (VMS)  

- Hormone replacement therapy (HRT) had neutral ASCVD risk  

Women 60–69:  

- Some symptom relief  

- Slightly higher estimated ASCVD risk, but no clear harm  

Women 70+:  

- Least symptom relief  

- Increased risk of ASCVD events  

Implications:  

- 50–59: MHT recommended for moderate to severe hot flashes  

- 60–69: Use with caution  

- 70+: Generally not recommended  

Takeaway: It is crucial to consult your healthcare providers about MHT, especially as menopause awareness continues to grow and new research emerges.

This summary, posted September 16, 2025, is based on the research article published in JAMA Intern Med, originally published September 15, 2025.

The National Menopause Foundation (NMF) and Perry announced that Governors from 12 states have issued proclamations declaring September 2025 as Menopause Awareness Month, highlighting the critical need for increased understanding of menopause and its effects on women's health. 

The states recognizing the importance of raising awareness include Colorado, Georgia, Illinois, Maryland, New Mexico, North Carolina, Ohio, Oregon, South Carolina, South Dakota, Vermont, and West Virginia. 

"Perimenopause can cause life-disrupting symptoms for millions of women," said Claire Gill, founder and president of NMF. "The changes that happen to women during this natural phase of life are not taught in schools or discussed during routine healthcare visits. We appreciate the state policy leaders who recognized the need to educate and support women at midlife and are helping raise awareness, so women are not suffering in silence." 

Menopause Spotlight supports the efforts of the National Menopause Foundation and Perry in advancing menopause research and awareness, particularly regarding FDA menopause approvals and hormone therapy updates, which are vital for postmenopausal treatments. 

This summary (posted September 4, 2025) is based on a PR Newswire report by the National Menopause Foundation, originally published September 2, 2025.

An article by Laura Ungar of the Associated Press discusses a recent FDA expert panel meeting where doctors debated whether hormone therapy updates should continue to feature the FDA's strongest health warning, known as a 'black box' warning. This warning is prominently displayed in a black box at the top of the prescribing information accompanying each prescription. 

According to Ungar’s reporting, the FDA-assembled panel highlighted the benefits of hormone therapies and suggested that some hormonal products may not require these health warnings. However, a letter signed by 76 doctors and researchers expressed concern that 'removing label warnings without adequate scientific assessment puts patients at risk,' urging the FDA to conduct menopause research and hold a public meeting before implementing any changes. 

Ungar also emphasizes the need for menopause awareness, as doctors caution against misinformation, particularly claims on social media suggesting that hormones can prevent dementia or guarantee healthy aging. Experts advise that while hormone therapy can be an effective option for many postmenopausal treatments, it's crucial to 'understand the nuanced reality of these treatments before deciding what’s best.'

This summary (posted August 28, 2025) is based on reporting by Laura Ungar, Associated Press, originally published August 23, 2025.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has made history as the first global regulator to approve Bayer's new drug, elinzanetant (also known as Lynkuet), for the treatment of moderate to severe hot flashes associated with menopause. This oral non-hormonal medication may also assist in alleviating night sweats due to menopause, marking an important development in menopause awareness and postmenopausal treatments. 

Elinzanetant received its approval following promising results from the OASIS clinical trials, a multinational study that involved over 1,400 women aged 40-65. Patients taking daily 120 mg elinzanetant capsules experienced significant reductions in hot flushes and night sweats over study durations ranging from 26 to 52 weeks, especially when compared to a placebo. Among the most common side effects reported were headache, fatigue, and drowsiness. 

Currently, elinzanetant is under review by the FDA for potential menopause approvals in the United States, and it offers hope as an alternative to traditional hormone therapy updates. 

This summary, posted on August 24, 2025, is based on a press release from the Medicines and Healthcare products Regulatory Agency, originally published on July 8, 2025.

An article on MSN highlights psychologist Dr. Kellyn Lee's insights on the key differences between menopause symptoms and dementia. While both conditions can lead to memory issues, brain fog, and mood changes, menopause is a temporary phase driven by hormonal shifts, whereas dementia is progressive and irreversible, resulting from brain shrinkage and deterioration. Recent hormone therapy updates indicate that Hormone Replacement Therapy (HRT) can alleviate menopausal symptoms but has no effect on dementia. Awareness around menopause and related research shows that menopausal symptoms typically improve over time, while dementia symptoms worsen and significantly disrupt daily life. This discussion is timely, especially with ongoing FDA menopause approvals aimed at improving postmenopausal treatments. 

This summary (posted August 24, 2025) is based on reporting by Lauren Haughey, published on the MSN News website on June 1, 2025.

A recent study from Ohio State University reveals that many U.S. women lack menopause awareness and feel uncertain about what to expect during this stage of life. The survey, conducted in February 2025 with 1,068 participants, found that 60% of women anticipated their first menopause symptoms to appear between the ages of 41 and 50, while 25% expected symptoms to begin after age 50. However, the reality is that signs of perimenopause can show up as early as the mid-30s. 

While nearly all the women surveyed (95%) recognized hot flashes as a symptom of menopause, awareness of other symptoms, such as hair loss and memory issues, was much lower, especially among women over 60. Additionally, only a quarter of women identified hormone therapy as a viable option for managing menopause symptoms. This reflects a need for more menopause research, particularly regarding FDA menopause approvals and the latest hormone therapy updates that can assist women during this transition. Younger women, aged 18 to 29, were the least likely to view hormone therapy as beneficial, often favoring lifestyle approaches like diet and exercise instead. 

This summary (posted August 24, 2025) is based on reporting by Roberta Burkhart, published on MedicalXpress on May 12, 2025, emphasizing the importance of improving awareness around postmenopausal treatments.

A recent AARP study highlighted the concerning fact that only 21% of menopausal women aged 45 to 64 received treatment for depressive disorders. Furthermore, merely 20% sought help for anxiety or fear-related conditions. This underscores the need for increased menopause awareness, especially in the context of in-progress menopause research and recent FDA menopause approvals related to postmenopausal treatments. This summary (posted August 24, 2025) is based on an article by Beth Carter from the AARP Public Policy Institute, published on the AARP.org website in April 2025.