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Prasterone (DHEA)
Prasterone (DHEA) is a steroid hormone precursor that acts as a substrate for the synthesis of estrogen and androgen, restoring hormonal balance in postmenopausal women.
Prasterone (DHEA) is a steroid hormone precursor that acts as a substrate for the synthesis of estrogen and androgen, restoring hormonal balance in postmenopausal women. Used for Moderate to severe dyspareunia due to genitourinary syndrome of menopause (GSM) in postmenopausal women, Vaginal atrophy and related menopausal symptoms.
At a glance
| Generic name | Prasterone (DHEA) |
|---|---|
| Also known as | Intrarosa |
| Sponsor | EndoCeutics Inc. |
| Drug class | Steroid hormone precursor |
| Target | Estrogen receptor (ER), Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Women's Health / Gynecology |
| Phase | Phase 3 |
Mechanism of action
Prasterone is an endogenous steroid hormone that serves as a precursor to both estrogen and testosterone. In postmenopausal women, systemic DHEA levels decline significantly, contributing to vaginal atrophy and related symptoms. By supplementing DHEA, the drug enables local and systemic conversion to active sex hormones, improving vaginal tissue health and alleviating symptoms of genitourinary syndrome of menopause (GSM).
Approved indications
- Moderate to severe dyspareunia due to genitourinary syndrome of menopause (GSM) in postmenopausal women
- Vaginal atrophy and related menopausal symptoms
Common side effects
- Vaginal discharge
- Vaginal irritation
- Perineal discomfort
- Headache
- Hot flashes
Key clinical trials
- Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial (PHASE2)
- Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease (NA)
- Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA ) (PHASE2)
- Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer (PHASE2)
- Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain (NA)
- Peri-Implant Sulcus Fluid Stress Markers in Health and Disease
- Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization (PHASE2, PHASE3)
- Effects of DHEA in Pulmonary Hypertension (PHASE2)
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:
- Prasterone (DHEA) CI brief — competitive landscape report
- Prasterone (DHEA) updates RSS · CI watch RSS
- EndoCeutics Inc. portfolio CI