THERAPY DOSSIER · th-6de86cded572

Dehydroepiandrosterone (DHEA)

Hormone · Not fully established. Prasterone is an inactive endogenous steroid that is converted to active estrogens and androgens.

No trauma translation Suggest a correction

Review required. This record is flagged as borderline.

This record is classified as “NO TRAUMA TRANSLATION”. Read the indication and notes below for the specific context.

Evidence & regulatory context

Mechanism: Not fully established. Prasterone is an inactive endogenous steroid that is converted to active estrogens and androgens.
Target: Not recorded
Injury models: Fracture · Chemical/toxin
Reported indication: Prasterone (DHEA) - Intrarosa approved (FDA 2016) for moderate-to-severe dyspareunia due to vulvar/vaginal atrophy of menopause; otherwise sold as a supplement
First approval: Not recorded
Development stage: Prasterone approved for menopausal dyspareunia; not approved for any acute injury
ChEMBL record: CHEMBL90593 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Dehydroepiandrosterone; Dehydroisoandrosterone; DHEA; Intrarosa; Prasterone; Isoandrostenolone; NSC-9896
Note: Not recorded

Clinical trials 9

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT04705883 ↗PHASE4completed

Trial title not recorded

Vulvar Atrophy · Breast Cancer · Genitourinary Syndrome of Menopause

Enrolment: 10 · Results not recorded

NCT03854396 ↗PHASE3withdrawn

Trial title not recorded

Recurrent Urinary Tract Infection · Postmenopause · Menopause

Enrolment: 0 · Results not recorded

NCT01846442 ↗PHASE3completed

Trial title not recorded

Vaginal Atrophy

Enrolment: 218 · Results not recorded

NCT04066478 ↗PHASE2/PHASE3suspended

Trial title not recorded

Infertility, Female · Poor Response to Ovulation Induction

Enrolment: 400 · Results not recorded

NCT00650754 ↗PHASE2/PHASE3terminated

Trial title not recorded

Primary Ovarian Insufficiency · Unexplained Infertility

Enrolment: 35 · Results not recorded

NCT01861847 ↗PHASE2completed

Trial title not recorded

PTSD

Enrolment: 71 · Results not recorded

NCT03227458 ↗NAcompleted

Trial title not recorded

Low Bone Mass · Osteoporosis, Postmenopausal

Enrolment: 152 · Results not recorded

NCT05434351 ↗NAterminated

Trial title not recorded

Genitourinary Syndrome of Menopause

Enrolment: 4 · Results not recorded

NCT02432248 ↗NAunknown

Trial title not recorded

Subfertility

Enrolment: 350 · Results not recorded

Preclinical evidence 2

2 studies reported at therapy level; 2 evidence entries itemised.

PMID 24886543 ↗2014Mixed findings

Dehydroepiandrosterone modulates the inflammatory response in a bilateral femoral shaft fracture model.

MouseFractureFemurC57/BL6Malen = 54 mice in total, 18 per group with 6 per time pointSubcutaneous injection into the nuchal fold25 mg/kg per 24 h, dissolved in 70% ethanol and diluted in…Directly after the fracture or sham operation

Model: Closed bilateral femoral shaft fracture produced with a standardised blunt guillotine device followed by retrograde intramedullary nailing with a 27G needle

DHEA lowered the systemic inflammatory response at 6 h, with IL-6 322.2 versus 62.5 pg/ml (p=0.01), IL-1 beta 1422.6 versus 754.1 pg/ml (p=0.05) and MCP-1 219.4 versus 44.1 pg/ml. KC, IL-10 and pulmonary inflammation were unchanged.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.95. Machine-extracted fields require source verification.

PMID 22015977 ↗2011Mixed findings

Administration of thimerosal to infant rats increases overflow of glutamate and aspartate in the prefrontal cortex: protective role of dehydroepiandrosterone sulfate.

RatChemical/toxinWistarMalen = Neonatal cohort N=28 (5 to 6 per group across five groups);…Intraperitoneal injection (neonatal model); intracerebral microdialysis perfusion (acute model)80 mg/kg intraperitoneally in the neonatal model; 100 micro…30 min before each thimerosal injection in the neonatal model; co-applied with…

Model: Thimerosal-induced excitotoxic amino acid imbalance in the prefrontal cortex, neonatal intramuscular exposure and acute intracerebral perfusion

DHEAS prevented the thimerosal-induced rise in extracellular glutamate and aspartate in both the neonatal and acute models, but by itself reduced glycine and alanine overflow and so added to the thimerosal effect on those inhibitory amino acids.

Extraction: extract · Supplied extraction confidence: 0.9. Machine-extracted fields require source verification.

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