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DHEA (0.5%)
DHEA (dehydroepiandrosterone) is a prohormone that is converted to testosterone and estrogen in peripheral tissues, restoring hormone levels in postmenopausal women.
DHEA (dehydroepiandrosterone) is a prohormone that is converted to testosterone and estrogen in peripheral tissues, restoring hormone levels in postmenopausal women. Used for Moderate to severe dyspareunia due to menopause-related vaginal atrophy, Vaginal atrophy and related menopausal symptoms.
At a glance
| Generic name | DHEA (0.5%) |
|---|---|
| Also known as | Prasterone, Dehydroepiandrosterone |
| Sponsor | EndoCeutics Inc. |
| Drug class | Prohormone; hormone replacement therapy |
| Target | Androgen receptor; estrogen receptor (via local conversion) |
| Modality | Small molecule |
| Therapeutic area | Gynecology; Menopause |
| Phase | Phase 3 |
Mechanism of action
DHEA is an endogenous steroid hormone precursor that declines with age. When administered as a 0.5% vaginal cream formulation (Prasterone), it is locally converted to active androgens and estrogens by tissue enzymes, providing hormone replacement therapy specifically for vaginal atrophy and related menopausal symptoms without systemic hormone exposure.
Approved indications
- Moderate to severe dyspareunia due to menopause-related vaginal atrophy
- Vaginal atrophy and related menopausal symptoms
Common side effects
- Vaginal discharge
- Vaginal irritation
- Headache
- Breast tenderness
Key clinical trials
- Studies of Sulfur Metabolism in Humans (EARLY_PHASE1)
- Vaginal DHEA for Women After Breast Cancer (PHASE2, PHASE3)
- DHEA Against Vaginal Atrophy - Safety Study of 12 Months (PHASE3)
- Topical DHEA Against Vaginal Atrophy (PHASE3)
- DHEA Against Vaginal Atrophy - 3-Month Efficacy Study (PHASE3)
- Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy (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:
- DHEA (0.5%) CI brief — competitive landscape report
- DHEA (0.5%) updates RSS · CI watch RSS
- EndoCeutics Inc. portfolio CI