Dehydroepiandrosterone
Other / unclassified targets PPARA via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Intrarosa | — | 2018-01-08 | europa.eu ↗ |
| Approved | US (FDA) | INTRAROSA | — | 2016-11-16 | fda.gov ↗ |
Trials 53 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03228732 Comparator | Dec 2017 → Sep 2026 expected | type 1 diabetes mellitus | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02229604 Background | Jan 2014 → Sep 2016 | menstrual disorder | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07535983 Background | Sep 2025 → Jan 2027 expected | ovarian dysfunction | Jiangxi University of Traditional Chinese Medicine | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03491007 Comparator | Jul 2019 → Nov 2020 | post-traumatic stress disorder | VA Office of Research and Development | Terminated | No outcome recorded |
| Phase 2 | NCT00566384 Comparator | Nov 2007 → Apr 2009 | — | Bayer | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT04898556 Comparator | Dec 2020 → May 2021 | postmenopausal atrophic vaginitis | Dr. Santiago Palacios | Unknown | No outcome recorded |
| Phase 3 | NCT03854396 Comparator | May 2020 → Feb 2021 | urinary tract infection | Olivia Cardenas-Trowers, M.D. | Withdrawn | No outcome recorded |
| Phase 3 | NCT03782480 Comparator | Mar 2019 → Jan 2021 | postmenopausal atrophic vaginitis | Center for Vulvovaginal Disorders | Unknown | No outcome recorded |
| Phase 3 | NCT03619005 Comparator | Nov 2018 → Aug 2019 | hypoactive sexual desire disorder | EndoCeutics Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02736591 Comparator | Jun 2016 → Apr 2017 | infertility disorder | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT02561793 Comparator | Oct 2015 → Sep 2017 | infertility disorder | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT02151006 Comparator | May 2014 → May 2015 | infertility disorder | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT02150330 Comparator | Jan → Oct 2013 | — | Taipei Veterans General Hospital, Taiwan | Completed | No outcome recorded |
| Phase 3 | NCT00575341 Comparator | Oct 2003 → Apr 2007 | secondary adrenal insufficiency | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05562518 Comparator | Mar 2022 → Mar 2026 overdue | breast cancer, postmenopausal atrophic vaginitis | University Hospital, Ghent | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05586711 Comparator | Dec 2020 → Dec 2024 | postmenopausal atrophic vaginitis | Angelica Lindén Hirschberg | Completed | No outcome recorded |
| Phase 4 | NCT00543166 Comparator | Feb 2003 → Dec 2009 | Sjogren syndrome | University of Helsinki | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07574216 Comparator | Jun 2026 → Dec 2031 expected | physiological sexual disorder, postmenopausal atrophic vaginitis | University of Arizona | Not yet recruiting | No outcome recorded |
| — | NCT00916396 Comparator | Jun 2005 → Jan 2011 | hypoactive sexual desire disorder | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 83 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dehydroepiandrosterone | “OBJECTIVE: Intravaginal DHEA (dehydroepiandrosterone, prasterone), the exclusive precursor of androgens and estrogens in postmenopausal women, has previously been shown to...” PMID 26725467 ↗ Mar 201651“To provide the best available evidence on the role of dehydroepiandrosterone (DHEA) treatment in improving the outcome of in vitro fertilization (IVF)/intracytoplasmic sperm...” PMID 26963897 ↗ Feb 2016 “The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome...” NCT07323329 ↗ “This study's purpose is to learn how dehydroepiandrosterone (DHEA) affects the HIV virus, the immune system, hormone levels, body composition and quality of life.” NCT00065104 ↗ “Group 1 ( study group) will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle.” NCT02561793 ↗ “Dehydroepiandrosterone (DHEA) and its sulfate (DHEAS) decrease with aging and are important androgen and estrogen precursors in older adults.” PMID 16735495 ↗ May 2006 “Age-related reductions in serum dehydroepiandrosterone (DHEA) concentrations may be involved in bone mineral density (BMD) losses.” PMID 19321570 ↗ Mar 2009 “Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells.” NCT00516542 ↗ “A single, therapeutic dose of acetaminophen (APAP, 1.0 g)) or dehydroepiandrosterone (DHEA, 75 mg) is taken orally” NCT03383133 ↗ “daily intravaginal administration of 0.50% dehydroepiandrosterone (DHEA; prasterone) ovules for 12 weeks” PMID 26291918 ↗ Aug 2015 “intravaginal dehydroepiandrosterone (DHEA, prasterone) improved all the domains of sexual function” PMID 26597311 ↗ Nov 2015 “DHEA or dehydroepiandrosterone is a naturally occurring hormone secreted by tghe adrenal galnds.” NCT00205686 ↗ “The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)” NCT03783988 ↗ “DHEA (dehydroepiandrosterone) is an inactive hormone precursor naturally produced by the body.” NCT07574216 ↗ “a study medication called Dehydroepiandrosterone (DHEA) helps to reduce PTSD symptoms” NCT03491007 ↗ “HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group.” NCT02229604 ↗ “It was previously shown that dehydroepiandrosterone (DHEA) reverses” PMID 22280813 ↗ Jan 2012 “Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries” NCT05586711 ↗ “Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA)” NCT02736591 ↗ “Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo” NCT00202163 ↗ “6.5 vaginal insert prasterone (dehydroepiandrosterone)” NCT03568604 ↗ “the adrenal hormone dehydroepiandrosterone (DHEA)” NCT00099697 ↗ “daily vaginal prasterone (dehydroepiandrosterone” NCT01376349 ↗ “dehydroepiandrosterone (DHEA)” NCT00317148 ↗ |
| Known as | BAY86-5314 | “Dehydroepiandrosterone, BAY86-5314” NCT00566384 ↗ |
| Known as | dehydroepiandrosterone (DHEA) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00900900 ↗ |
| Known as | dehydroepiandrosterone sulphate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00442403 ↗ |
| Known as | DHEA | “The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration improves fatigue and general well-being in patients with systemic lupus...” NCT00391924 ↗43“The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome...” NCT07323329 ↗ “All participants (in both the treatment and control groups) concurrently took dehydroepiandrosterone (DHEA) tablets (25 mg per tablet; Fosun Pharma, USA) at a dosage of 25 mg...” NCT07535983 ↗ “Dehydroepiandrosterone (DHEA) has been proposed to improve pregnancy rates in women with diminished ovarian reserve undergoing in vitro fertilisation (IVF) treatment.” PMID 25296654 ↗ Oct 2014 “Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).” NCT00004313 ↗ “Group 1 ( study group) will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle.” NCT02561793 ↗ “Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells.” NCT00516542 ↗ “dehydroepiandrosterone (DHEA) supplementation on in vitro fertilization (IVF) data and outcomes among poor-responder patients” PMID 20729538 ↗ Aug 2010 “To investigate the effect of dehydroepiandrosterone (DHEA) supplementation on women with poor ovarian response (POR).” PMID 25951716 ↗ Apr 2015 “daily intravaginal administration of 0.50% dehydroepiandrosterone (DHEA; prasterone) ovules for 12 weeks” PMID 26291918 ↗ Aug 2015 “intravaginal dehydroepiandrosterone (DHEA, prasterone) improved all the domains of sexual function” PMID 26597311 ↗ Nov 2015 “Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study” NCT03619005 ↗ “HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group.” NCT02229604 ↗ “Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)” NCT03287232 ↗ “Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders?” NCT04066478 ↗ “Dehydroepiandrosterone (DHEA) is a hormone produced by the adrenal gland.” NCT00001487 ↗ “Daily Oral 100 mg Dehydroepiandrosterone (DHEA) Over 6 Treatment Cycles” NCT00566384 ↗ “acetaminophen (APAP, 1.0 g)) or dehydroepiandrosterone (DHEA, 75 mg)” NCT03383133 ↗ “Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries” NCT05586711 ↗ “Dehydroepiandrosterone (DHEA) Treatment for Sjogren's Syndrome” NCT00001598 ↗ “oral androgen challenge with dehydroepiandrosterone (DHEA)” NCT05246865 ↗ “locally administered dehydroepiandrosterone (DHEA)” NCT05562518 ↗ “Inflabloc Cap (Dehydroepiandrosterone [DHEA])” NCT00106314 ↗ “Prasterone (DHEA), Micronized” NCT04705883 ↗ “dehydroepiandrosterone (DHEA)” NCT00471900 ↗ “Dehydroepiandrosterone (DHEA)” NCT00189124 ↗ “Prasterone (DHEA)” NCT06611514 ↗ |
| Known as | Dheas | “Etude de l'Activite (Efficacite et Tolerance) de l'Association de la Chloroquine Avec la Dehydroepiandrosterone-Sulfate (Dheas) Dans le Traitement de l'Acces Palustre Simple A...” NCT00442403 ↗ |
| Known as | GL701 | “Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.” NCT00004662 ↗5“synthetic formulation of dehydroepiandrosterone, GL701” NCT00004665 ↗ “synthetic dehydroepiandrosterone (GL701)” NCT00004795 ↗ “Prasterone (GL701)” NCT00082511 ↗ “Prasterone (GL701)” NCT00053560 ↗ |
| Known as | Inflabloc Cap | “Inflabloc Cap (Dehydroepiandrosterone [DHEA])” NCT00106314 ↗ |
| Known as | Intrarosa | “The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.” NCT04898556 ↗2“Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries” NCT05586711 ↗ “Drug: Intrarosa” NCT03782480 ↗ |
| Known as | prasterone | “OBJECTIVE: Intravaginal DHEA (dehydroepiandrosterone, prasterone), the exclusive precursor of androgens and estrogens in postmenopausal women, has previously been shown to...” PMID 26725467 ↗ Mar 201618“Intravaginal prasterone (DHEA) provides local action without clinically significant changes in serum concentrations of estrogens or androgens.” PMID 23954500 ↗ Aug 2013 “Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries” NCT05586711 ↗ |
| Action | Activate | “DHEA is a PPAR-alpha activator.” NCT00182975 ↗ |
| Modality | Other / unclassified | “dehydroepiandrosterone (DHEA), an androgen replacement hormone” NCT00004313 ↗ |
| Route | Oral | “Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks.” NCT00004662 ↗ |
| Target | PPARA | “DHEA is a PPAR-alpha activator.” NCT00182975 ↗ |