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intravaginal prasterone
Intravaginal prasterone is a vaginal progesterone that mimics the natural hormone progesterone to treat symptoms of menopause.
Intravaginal prasterone is a vaginal progesterone that mimics the natural hormone progesterone to treat symptoms of menopause. Used for Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.
At a glance
| Generic name | intravaginal prasterone |
|---|---|
| Also known as | Intrarosa |
| Sponsor | Lee's Pharmaceutical Limited |
| Drug class | Progesterone |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Gynecology |
| Phase | Phase 3 |
Mechanism of action
It works by promoting the growth of the vaginal epithelium, increasing the levels of progesterone in the vagina, and reducing the symptoms of vaginal atrophy. This is achieved by mimicking the natural hormone progesterone, which is essential for maintaining the health of the vaginal tissue.
Approved indications
- Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause
Common side effects
- Vaginal discharge
- Vaginal bleeding
Key clinical trials
- Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer (PHASE3)
- A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy (PHASE3)
- Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women (PHASE3)
- Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) (PHASE3)
- Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer (PHASE3)
- Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study (PHASE3)
- Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy (PHASE3)
- DHEA Against Vaginal Atrophy - Safety Study of 12 Months (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- intravaginal prasterone CI brief — competitive landscape report
- intravaginal prasterone updates RSS · CI watch RSS
- Lee's Pharmaceutical Limited portfolio CI