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DHEA Pessaries for Genitourinary Syndrome of Menopause (GSM) in the UK: Exploring the Rationale Behind Licensing






DHEA pessaries are licensed for the treatment of genitourinary syndrome of menopause (GSM) in the UK. This blog explores the rationale behind their licensing and delves into the benefits of testosterone for vaginal atrophy, using information from NICE guidelines and the MHRA.


Understanding Genitourinary Syndrome of Menopause (GSM)

GSM encompasses a variety of symptoms that affect the genital and urinary systems due to decreased estrogen levels during menopause. Common symptoms include vaginal dryness, irritation, discomfort, and urinary issues. These symptoms can significantly impact the quality of life, making effective treatments essential.


DHEA Pessaries: The Rationale Behind Licensing

DHEA (dehydroepiandrosterone) is a hormone that serves as a precursor to both estrogen and testosterone. DHEA pessaries are inserted into the vagina, where they are metabolized into these active hormones, directly addressing the symptoms of GSM.

Benefits of DHEA Pessaries

  1. Targeted Hormone Delivery: DHEA pessaries deliver hormones directly to the vaginal tissues, ensuring localized action with minimal systemic absorption.

  2. Improved Vaginal Health: The conversion of DHEA to estrogen and testosterone within the vaginal tissues helps restore their thickness, elasticity, and lubrication.

  3. Symptom Relief: Regular use of DHEA pessaries can alleviate symptoms of vaginal dryness, discomfort, and urinary issues, improving overall quality of life.


NICE Guidelines on DHEA Pessaries

The National Institute for Health and Care Excellence (NICE) provides comprehensive guidelines for the management of menopause and associated symptoms. According to NICE, DHEA pessaries are a valuable option for women who cannot or prefer not to use systemic hormone replacement therapy (HRT). They are particularly beneficial for those primarily experiencing vaginal symptoms.


MHRA Approval and Safety

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of DHEA pessaries for GSM based on evidence of their efficacy and safety. Clinical trials have demonstrated significant improvements in vaginal health and symptom relief with minimal side effects.


DHEA Not Licensed in Australia

It is important to note that while DHEA pessaries are licensed and available in the UK, they are not currently licensed for use in Australia. Women in Australia should consult with their healthcare providers for alternative treatments available within their regulatory framework.


The Role of Testosterone in Vaginal Health

While DHEA is a precursor to both estrogen and testosterone, this blog also explores the specific benefits of testosterone for vaginal atrophy, supported by NICE guidelines and MHRA information.

Testosterone's Contribution to Vaginal Health

  1. Tissue Regeneration: Testosterone promotes the production of collagen and elastin, essential for the structural integrity and elasticity of vaginal tissues.

  2. Enhanced Blood Flow: Increased testosterone levels improve blood circulation to the vaginal area, ensuring adequate oxygen and nutrient delivery to the tissues.

  3. Increased Lubrication: Testosterone can enhance natural lubrication, reducing vaginal dryness and discomfort.


NICE Guidelines on Testosterone Therapy

NICE guidelines recognize testosterone therapy as a beneficial option for women experiencing symptoms of low libido and vaginal atrophy when estrogen therapy alone is insufficient. They recommend considering testosterone therapy after evaluating the individual needs and health conditions of the patient.


MHRA Recommendations

The MHRA emphasizes the importance of careful monitoring and individualized dosing in testosterone therapy. They highlight the need for regular follow-ups to ensure the therapy's efficacy and to adjust dosages as necessary to minimize potential side effects.

Conclusion

The licensing of DHEA pessaries for GSM in the UK underscores the importance of effective, targeted treatments for menopausal symptoms. By delivering localized hormone therapy, DHEA pessaries offer significant relief from vaginal dryness, discomfort, and urinary issues.

Moreover, testosterone's role in maintaining vaginal health cannot be overlooked. Its benefits in promoting tissue regeneration, enhancing blood flow, and increasing lubrication make it a valuable option for women experiencing vaginal atrophy.

For those considering hormone therapy for GSM, consulting with a healthcare provider is crucial. They can provide personalized recommendations based on individual health needs, ensuring the most effective and safe treatment.

By understanding the rationale behind the licensing of DHEA pessaries and the benefits of testosterone for vaginal atrophy, women can make informed decisions about their health and find the relief they need to improve their quality of life.


References

  1. NICE Guidelines on Menopause:

  • NICE provides comprehensive guidelines for the diagnosis and management of menopause. Their guidelines emphasize the importance of personalized care and include recommendations for hormone replacement therapies, including DHEA pessaries and testosterone therapy.

  • NICE Guidelines on Menopause

  1. MHRA Approval for DHEA Pessaries:

  • The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has evaluated and approved the use of DHEA pessaries for GSM based on clinical evidence of their efficacy and safety.

  • MHRA

  1. Clinical Trials and Studies:

  • Research studies have demonstrated the benefits of DHEA pessaries in improving vaginal health and alleviating symptoms of GSM. These studies provide the evidence base for their approval and use in clinical practice.

  • Labrie, F., et al. (2009). Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy. Maturitas, 63(1), 47-52.

  • Study on DHEA Efficacy

  1. Testosterone Therapy in Women:

  • NICE guidelines also include recommendations for the use of testosterone therapy in women, particularly for those experiencing low libido and symptoms of vaginal atrophy that are not adequately managed by estrogen therapy alone.

  • NICE Guidelines on Testosterone Therapy

  1. Journal Articles on Testosterone and Vaginal Health:

  • Several journal articles explore the role of testosterone in maintaining vaginal health, tissue regeneration, and lubrication, providing a scientific basis for its use in treating vaginal atrophy.

  • Davis, S. R., & Braunstein, G. D. (2012). Efficacy and safety of testosterone in the management of hypoactive sexual desire disorder in postmenopausal women. Journal of Sexual Medicine, 9(4), 1134-1148.

  • Journal of Sexual Medicine




By Dr Purity Carr

GP & Menopause Doctor

Harvey, WA

Comments

Welcome to Purity Health Women’s Menopause and Wellbeing Centre™

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At Purity Health, we believe in living life to the fullest. Dr Purity Menopause Clinic, in association with Samy Medical Group, is dedicated to providing safe, evidence based information and care in perimenopause, menopause, histamine related conditions, and metabolic health.

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We recognise that there are many myths and misunderstandings surrounding menopause and Hormone Replacement Therapy, HRT. One commonly repeated belief is that oestrogen causes breast cancer. This is an oversimplification and does not reflect the full body of evidence.

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Here is the truth.

At Dr Purity Carr Menopause Clinic, we are committed to providing accurate information and personalised care.

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Extensive evidence shows that for women within 10 years of menopause or under the age of 60, the benefits of HRT generally outweigh the risks.

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For women who start HRT during perimenopause or within 10 years of menopause, there is often no need to stop purely based on age. Ongoing use should be individualised and guided by clinical review.

Even for women who are further beyond menopause or over 60, starting HRT may still be considered under the guidance of a knowledgeable practitioner, with careful assessment of risks and benefits.

​

A Broader Approach to Women’s Health

Dr Purity is a General Practitioner with a special interest in menopause care, taking a holistic, systems based approach to women’s health.

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In addition to menopause, her work now includes:

Hormone health, including perimenopause and menopause
Histamine related conditions, including suspected mast cell activation patterns
Metabolic health, including weight management, insulin resistance, and inflammation
The interaction between hormones, the immune system, and the nervous system

Many women experience symptoms that do not sit neatly within one system. Hormones do not operate in isolation. There is often an overlap between hormonal changes, histamine activity, and metabolic dysfunction. This integrated approach allows for a deeper understanding of symptoms such as fatigue, anxiety, poor sleep, weight gain, brain fog, and chronic inflammation.

 

Dr Purity’s Focus on Care

Dr Purity focuses specifically on menopause, histamine balance, and metabolic health. She works to identify underlying drivers of symptoms and supports women through evidence based, personalised care.

Please note that Dr Purity does not replace your general practitioner. The experienced doctors at Samy Medical, part of the same medical system as Purity Health, are available to manage your broader healthcare needs.

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