Hormonal health
Female sexual arousal disorder treatment study shows positive findings

Women’s health company Daré Bioscience has announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), has shown positive results.
The exploratory Phase 2b RESPOND study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them, or the patient-reported outcome (PRO) measures, that best reflect that improvement.
The subset analyses compared efficacy endpoints based on study product use in pre-planned and post-hoc subsets of age, race, and medication use to help refine target populations in future studies of Sildenafil Cream, 3.6% for the treatment of FSAD.
“We believe that these data are an indication of the broad population of premenopausal women with FSAD who could potentially benefit from treatment with Sildenafil Cream,” said Sabrina Martucci Johnson, president and CEO of Daré Bioscience.
“We were pleased to see that age and race did not significantly impact response to Sildenafil Cream.”
“This analysis also explored other subgroups such as hormonal contraceptive users versus non-users,” said Dr. Annie Thurman, medical director at Daré Bioscience.
“Since hormonal contraceptive use has been associated with lower sexual desire as well as reduced sexual arousal in other studies, we wanted to understand how this medication use might impact the effect of Sildenafil Cream.
“Our data show, however, that there was no significant impact from hormonal contraceptive use on either the primary or secondary efficacy endpoints, so we were also pleased to see that hormonal contraceptive users could also potentially benefit from Sildenafil Cream.”
As previously announced, safety and efficacy data from the Phase 2b RESPOND study have been published in The Journal of Sexual Medicine and Obstetrics & Gynecology, respectively:
Thurman, et al. “Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder.” The Journal of Sexual Medicine, 2024, 1-7. https://doi.org/10.1093/jsxmed/qdae089
Johnson, et al. “Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial.” Obstetrics & Gynecology, 144(2):p 144-152, August 2024. DOI: 10.1097/AOG.0000000000005648
Menopause
Statins may worsen menopause symptoms, study suggess

Statins have been linked to more severe menopause symptoms and a higher risk of muscle loss in postmenopausal women, a study suggests.
The medicines are among the most widely prescribed in the world, with strong evidence supporting their use to lower cholesterol and reduce cardiovascular risk.
However, some recognised side effects may resemble symptoms associated with menopause, raising questions about how the two could interact.
The US Food and Drug Administration has flagged potential adverse effects linked to statin treatment, some of which overlap with menopausal complaints.
Researchers examined data from 1,184 postmenopausal women across nine Latin American countries, assessing menopausal symptoms, sarcopenia risk and cognitive function.
They compared women taking statins with non-users after accounting for factors including age and body weight.
As the study was cross-sectional, meaning it examined information collected at one point in time, it could identify associations but could not prove that statins caused the outcomes.
Women taking statins were 56 per cent more likely to have severe menopausal symptoms than those who were not using the medicines.
The difference remained after researchers accounted for other variables.
Statin users were also 65 per cent more likely to be at risk of sarcopenia.
Sarcopenia is the gradual loss of muscle mass and physical function, which tends to accelerate after menopause.
Declining oestrogen levels already make muscle loss a concern at this stage of life. It is linked to a higher risk of falls, fractures and reduced quality of life.
Musculoskeletal symptoms were reported by 53.1 per cent of statin users, compared with 33.9 per cent of non-users.
Researchers said this was separate from the finding on sarcopenia risk and may point to a wider pattern of physical discomfort among women taking the medicines.
Women taking statins also recorded slightly lower scores in tests of delayed memory recall and visuospatial function.
Visuospatial function is the ability to understand the position of objects and their relationship to one another.
The study found no overall association between statin use and mild cognitive impairment, so the differences in individual tests are early signals rather than firm conclusions.
Researchers said effects associated with statins may overlap with menopausal symptoms and add to the overall symptom burden during midlife.
This means symptoms attributed to menopause and possible statin side effects may look similar and, in some cases, could compound one another.
Further research is needed to separate the possible effects of the medicines from symptoms linked to menopause.
The findings are not a reason for women to stop taking statins.
Their cardiovascular benefits are well established, and stopping treatment without medical guidance can carry serious risks.
The study provides more information about what statin treatment may mean specifically for postmenopausal women, who have historically been under-represented in cardiovascular research.
Women who notice more severe menopausal symptoms or changes in muscle strength or physical function while taking statins should discuss them with a doctor.
A healthcare professional may consider whether the symptoms could be related to the medication and whether screening for muscle loss is appropriate.
They may also review whether the current statin remains the most suitable option, as different statins can have different side-effect profiles.
Resistance training and consuming enough protein are well-supported ways to help preserve muscle mass during midlife.
Statins can be life-saving, but the findings suggest their possible side effects should receive greater attention in postmenopausal women.
The study adds to evidence supporting more individualised care for women during midlife.
Menopause
Hormone therapy users report healthier lifestyles

Menopausal women using hormone therapy reported healthier diet, exercise and sleep habits than non-users in a study of more than 10,000 women.
The menopause transition is associated with a higher risk of chronic health conditions and symptoms including hot flushes and problems affecting the urinary and genital systems.
Hormone therapy is often used to manage these symptoms, but it remains unclear whether it affects health outcomes directly or indirectly through changes in health behaviours.
Previous research has produced mixed results, with some studies suggesting that postmenopausal women pay greater attention to maintaining a healthy lifestyle.
The cross-sectional analysis examined whether menopause status and hormone therapy use were linked to diet, physical activity and sleep duration.
A cross-sectional study assesses participants at one point in time. It can identify associations but cannot establish whether one factor directly caused another.
Diet, exercise and sleep are described as modifiable health behaviours because people may be able to change them to improve their health.
The researchers found that postmenopausal women who had never used hormone therapy reported eating less fruit and vegetables.
Women who had never used the treatment were also 19 per cent less likely to meet guidelines for muscle-strengthening activity.
Sleep duration was shorter among postmenopausal women who had never used hormone therapy.
Compared with premenopausal and perimenopausal women, the likelihood of meeting sleep guidelines was 14 per cent lower among never-users, 26 per cent lower among current users and 24 per cent lower among past users.
Perimenopause is the transitional period before menopause, when hormone levels and menstrual periods can change.
Researchers said these findings may be linked to higher levels of follicle-stimulating hormone among postmenopausal women who do not use hormone therapy.
They may also relate to lower levels of oestradiol, a form of oestrogen, which have previously been associated with poorer sleep.
Hot flushes and urogenital symptoms can also disrupt sleep, although hormone therapy may ease these symptoms.
Dr Stephanie Faubion, medical director for The Menopause Society, said: “This large observational study underscores that women who use hormone therapy tend to adopt overall healthier lifestyles.
“Although this association may partly reflect better symptom control enabling healthier behaviours, healthy-user bias is likely a significant contributor.
“Women who choose to use hormone therapy are often more proactive in their healthcare and may systematically differ from nonusers in socioeconomic resources, access to care, and health literacy.
“This largely explains why early observational studies of hormone therapy suggested cardiovascular benefits that were not confirmed in subsequent randomised, controlled trials.”
Hormonal health
Weight loss jab shows early promise in improving PMOS fertility

A weight loss jab may improve fertility outcomes in women with PMOS, early findings from an ongoing clinical trial suggest.
The proof-of-concept analysis found that injectable semaglutide may offer reproductive benefits while also addressing obesity and metabolic dysfunction.
It is the first report to examine how injectable semaglutide may improve reproductive outcomes in women with PMOS while also addressing obesity and metabolic dysfunction.
The work forms part of the ongoing RESTORE clinical trial.
Melanie Cree, professor at CU Anschutz and first author of the report, said: “Women with PMOS frequently face a frustrating choice between treatments that target reproductive symptoms and those that address metabolic health.
“Our early findings suggest injectable semaglutide may have the potential to improve both, offering a more comprehensive approach to care.
“This medication is incredibly promising when someone responds with 10 per cent weight loss.”
The trial is examining whether semaglutide can restore ovulation and improve reproductive health in adolescents and adults with polyendocrine metabolic ovarian syndrome, known as PMOS.
PMOS, formerly known as polycystic ovary syndrome or PCOS, is a hormone and metabolic condition linked to irregular periods, raised testosterone levels, infertility risk, obesity and increased cardiometabolic disease.
Cardiometabolic disease refers to conditions linked to the heart and metabolism, such as heart disease, high blood pressure and type 2 diabetes.
Existing treatments, including metformin and hormonal contraceptives, often do not fully address reproductive and metabolic complications at the same time.
The analysis focused on participants aged 12 to 35 who lost at least 10 per cent of their body weight during treatment.
Researchers said reproductive improvements appeared earlier than expected, prompting them to report preliminary findings while the wider study continues.
Cree is also a paediatric endocrinologist at Children’s Hospital Colorado.
Endocrinologists are doctors who specialise in hormones and hormone-related conditions.
Cree said: “What makes this work particularly important is that it focuses specifically on women with PMOS receiving injectable semaglutide.
“Although GLP-1 medications have transformed obesity treatment, there remains a significant need for rigorous data examining how these therapies affect fertility and reproductive function in this population.”
The RESTORE study is evaluating semaglutide treatment in girls and women with PMOS and obesity.
Its broader aim is to determine whether weight loss and metabolic improvements can restore ovulation and improve reproductive outcomes.
Ovulation is the release of an egg from the ovary, a key part of the menstrual cycle and fertility.
The authors said the findings are from an early proof-of-concept analysis and that larger, longer-term studies will be needed to confirm whether the reproductive benefits last.
The findings suggest injectable semaglutide may become a treatment option for women with PMOS seeking improvements in both metabolic and reproductive health, if future studies confirm the results.
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