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Prasterone

Prasterone, also known as dehydroepiandrosterone (DHEA) or Intrarosa, is being studied in various clinical trials for its potential benefits in treating menopausal symptoms, vaginal atrophy, and autoimmune conditions like lupus. This article summarizes key findings from recent clinical trials investigating the use of prasterone in different patient populations.

Table of Contents

What is Prasterone?

Prasterone, also known as dehydroepiandrosterone (DHEA) or Intrarosa, is a synthetic version of a hormone naturally produced by the human body[1]. It’s a medication that has been approved by the U.S. Food and Drug Administration (FDA) for treating certain menopausal symptoms[2]. Prasterone is a type of steroid hormone that can be converted into both estrogen and testosterone in the body.

Conditions Treated with Prasterone

Prasterone is primarily used to treat the following conditions:

  • Genitourinary Syndrome of Menopause (GSM): This is a group of symptoms affecting the genital and urinary systems in menopausal women. It includes vaginal dryness, irritation, and pain during sexual intercourse (dyspareunia)[4].
  • Vulvovaginal Atrophy (VVA): This is a condition where the vaginal tissues become thin, dry, and inflamed due to a lack of estrogen[9].
  • Recurrent Urinary Tract Infections (UTIs): Some studies are investigating if prasterone can help prevent recurrent UTIs in postmenopausal women[2].
  • Vaginal Symptoms in Cancer Survivors: Research is being conducted on the use of prasterone for vaginal symptoms in cancer survivors, particularly those who have had breast cancer[7].

How Prasterone Works

Prasterone works by being converted into estrogen and testosterone in the body. These hormones help to improve the health and function of vaginal tissues. Specifically:

  • It increases the number of superficial cells in the vagina, which helps maintain vaginal health[9].
  • It decreases the number of parabasal cells, which are associated with vaginal atrophy[9].
  • It helps to lower vaginal pH, creating a healthier vaginal environment[9].
  • It may improve vaginal lubrication and reduce pain during sexual intercourse[1].

How Prasterone is Administered

Prasterone is typically administered as a vaginal insert. The most common dosage is 6.5 mg, inserted into the vagina once daily at bedtime[1][9]. It’s important to follow your doctor’s instructions carefully when using this medication.

Effectiveness of Prasterone

Clinical trials have shown that prasterone can be effective in treating symptoms of GSM and VVA. Some key findings include:

  • Improvement in vaginal dryness and pain during intercourse[1].
  • Positive changes in vaginal pH and cell composition[9].
  • Potential improvement in sexual function and quality of life[9].

Potential Side Effects

While prasterone is generally well-tolerated, it may cause some side effects. These can include:

  • Vaginal discharge
  • Genital itching or irritation
  • Urinary tract infections

It’s important to discuss any side effects with your healthcare provider[9].

Ongoing Research

Researchers are continuing to study prasterone for various uses:

  • Its potential in preventing bone loss in women with lupus who are taking glucocorticoids[6].
  • Its use in breast cancer survivors experiencing vaginal symptoms[3][7].
  • Its effectiveness in preventing recurrent urinary tract infections in postmenopausal women[2].

As with any medication, it’s crucial to consult with your healthcare provider to determine if prasterone is appropriate for your specific situation.

Aspect Details
Main Conditions Studied Genitourinary Syndrome of Menopause, Vulvovaginal Atrophy, Dyspareunia, Recurrent Urinary Tract Infections, Bone Loss in Lupus
Dosage Forms Vaginal inserts/ovules (typically 6.5 mg)
Treatment Duration 12-26 weeks, some up to 12 months
Primary Outcomes Changes in vaginal cell composition, vaginal pH, symptom severity, bone mineral density
Secondary Outcomes Sexual function, quality of life, urinary symptoms, serum hormone levels
Special Populations Postmenopausal women, breast cancer survivors, women with lupus
Safety Monitoring Adverse events, serum hormone levels, vaginal health assessments

FAQ

  • What is prasterone and how does it work? Prasterone is a synthetic version of DHEA, a hormone naturally produced by the body. It can be converted into estrogen and testosterone in the body, potentially helping to alleviate symptoms related to hormone deficiencies.
  • What conditions is prasterone being studied for in clinical trials? Prasterone is being investigated for genitourinary syndrome of menopause (GSM), vulvovaginal atrophy, dyspareunia (painful intercourse), recurrent urinary tract infections in postmenopausal women, and bone loss prevention in women with lupus.
  • How is prasterone administered in these trials? In most trials, prasterone is administered as a vaginal insert or ovule, typically containing 6.5 mg of prasterone, to be used daily or every other day.
  • Are there any potential side effects of prasterone? While specific side effects are not detailed in the trial summaries, researchers are monitoring for any adverse events related to the study drug. Some trials are also measuring serum hormone levels to ensure safety.
  • How long do the clinical trials for prasterone typically last? The duration of the trials varies, but many last between 12 to 26 weeks, with some extending up to 12 months to assess long-term effects and safety.

Ongoing Clinical Trials on Prasterone

  • Study on the Effect of Prasterone on Genitourinary Syndrome in Postmenopausal Women with a History of Breast Cancer or Undergoing Anti-Hormonal Therapy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Testing dehydroepiandrosterone combined with standard antidepressants for patients with treatment-resistant depression

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Comparison of estriol, prasterone and estriol with lactobacillus for vulvovaginal atrophy in breast cancer patients on endocrine therapy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Prasterone: A synthetic form of dehydroepiandrosterone (DHEA), a hormone that can be converted into estrogen and testosterone in the body.
  • Genitourinary Syndrome of Menopause (GSM): A collection of symptoms affecting the genitals, urinary system, and sexual function in menopausal women, often due to lowered estrogen levels.
  • Vulvovaginal Atrophy: Thinning, drying, and inflammation of the vaginal walls due to a decrease in estrogen, often occurring after menopause.
  • Dyspareunia: Pain during sexual intercourse, often a symptom of vulvovaginal atrophy in menopausal women.
  • Aromatase Inhibitor: A class of drugs used in breast cancer treatment that lower estrogen levels in the body.
  • Bone Mineral Density (BMD): A measure of bone density used to diagnose osteoporosis and assess the risk of bone fractures.
  • Maturation Index: A measure of vaginal health based on the proportions of different types of vaginal cells, used to assess the degree of vaginal atrophy.
  • Vaginal pH: A measure of vaginal acidity, which can indicate vaginal health and the presence of atrophy.
  • Systemic Lupus Erythematosus (SLE): An autoimmune disease that can affect various parts of the body, including joints, skin, kidneys, and other organs.
  • Glucocorticoids: A class of steroid hormones used to treat inflammation in conditions like lupus, but which can cause side effects such as bone loss.

References

  1. https://clinicaltrials.gov/study/NCT03568604
  2. https://clinicaltrials.gov/study/NCT03854396
  3. https://clinicaltrials.gov/study/NCT06611514
  4. https://clinicaltrials.gov/study/NCT03782480
  5. https://clinicaltrials.gov/study/NCT04705883
  6. https://clinicaltrials.gov/study/NCT00082511
  7. https://clinicaltrials.gov/study/NCT01376349
  8. https://clinicaltrials.gov/study/NCT00053560
  9. https://clinicaltrials.gov/study/NCT04982692