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 52
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03383133 | Jan 2018 → Feb 2023 | — | Albert Einstein College of Medicine | Completed | No outcome recorded |
| Phase 0 | NCT00607646 | Oct 2010 → Oct 2018 | type 1 diabetes mellitus | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT03783988 | Jan → Jun 2019 | skin atrophy | Trophea Development AB | Unknown | No outcome recorded |
| Phase 1 | NCT03967964 | Nov 2015 → Jul 2016 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00516542 | Jun 2007 → Jul 2009 | breast cancer | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00429806 | Nov 2006 → Mar 2007 | postmenopausal atrophic vaginitis | CHU de Quebec-Universite Laval | Completed | No outcome recorded |
| Phase 211 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07407647 | Mar → Dec 2026 expected | anal carcinoma, cervical carcinoma, vaginal carcinoma, vulvar carcinoma | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04493333 | Jun 2021 → Jul 2023 | female breast carcinoma, postmenopausal atrophic vaginitis | University of Arkansas | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01273259 | May 2008 → Jun 2015 | chronic obstructive pulmonary disease, pulmonary hypertension | University Hospital, Bordeaux | Completed | Met primary |
| Phase 2 | NCT00202163 | Dec 2006 → Jul 2007 | erectile dysfunction | Queen's University | Completed | No outcome recorded |
| Phase 2 | NCT00106314 | Jan 2005 → Oct 2006 | Crohn disease | Inflabloc Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00065104 | Oct 2000 → Apr 2003 | HIV infectious disease | National Center for Complementary and Integrative Health (NCCIH) | Completed | No outcome recorded |
| Phase 2 | NCT00006219 | Aug 2000 → Dec 2006 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00391924 | May 2000 → Jan 2003 | Sjogren syndrome, systemic lupus erythematosus | UMC Utrecht | Completed | Missed primary |
| Phase 2 | NCT00001598 | May 1997 → Jun 2002 | Sjogren syndrome | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2 | NCT00001487 | Jun 1995 → Apr 2004 | depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 2 | NCT00004665 | Jun 1995 → ? | systemic lupus erythematosus | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2/36 trials · 1 missed | ||||||
| Phase 2/3 | NCT07323329 | Oct 2025 → Oct 2026 expected | infertility disorder | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04066478 | Oct 2017 → Dec 2022 | female infertility due to oocyte meiotic arrest | Homerton University Hospital NHS Foundation Trust | Suspended | No outcome recorded |
| Phase 2/3 | NCT00317148 | Aug 2005 → Sep 2006 | — | CHU de Quebec-Universite Laval | Completed | No outcome recorded |
| Phase 2/3 | NCT00167609 | Nov 2004 → Dec 2006 | myotonic dystrophy | University of Versailles | Completed | Missed primary |
| Phase 2/3 | NCT00189124 | Sep 2003 → Dec 2005 | systemic lupus erythematosus | University of Michigan | Completed | No outcome recorded |
| Phase 2/3 | NCT00004795 | Aug 1994 → ? | systemic lupus erythematosus | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 320 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT07843927 | Jun 2026 → Sep 2028 expected | — | Charite University, Berlin, Germany | Recruiting | No outcome recorded |
| Phase 3 | NCT06611514 | Dec 2024 → Jan 2027 expected | female breast carcinoma | European Institute of Oncology | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04982692 | Sep 2021 → Jan 2023 | postmenopausal atrophic vaginitis | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 3 | NCT07609043 | Jan → Dec 2020 | metabolic syndrome X | University of Guanajuato | Completed | No outcome recorded |
| Phase 3 | NCT03740945 | Nov 2018 → Dec 2019 | postmenopausal atrophic vaginitis | EndoCeutics Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03287232 | Oct 2017 → Mar 2019 | hypoactive sexual desire disorder | EndoCeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02013544 | Feb 2014 → Jan 2015 | postmenopausal atrophic vaginitis | EndoCeutics Inc. | Completed | Met primary |
| Phase 3 | NCT01572025 | May 2012 → Dec 2014 | infertility disorder, ovarian dysfunction | University of Nottingham | Completed | No outcome recorded |
| Phase 3 | NCT01376349 | Jul 2011 → Aug 2013 | breast cancer, female reproductive organ cancer | Alliance for Clinical Trials in Oncology | Completed | Missed primary |
| Phase 3 | NCT01256671 | Dec 2010 → Jul 2012 | postmenopausal atrophic vaginitis | EndoCeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00581087 | Jan 2007 → Jun 2015 | chronic obstructive pulmonary disease, pulmonary hypertension | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 3 | NCT00289926 | Feb 2006 → Apr 2008 | hypoactive sexual desire disorder | Monash University | Completed | No outcome recorded |
| Phase 3 | NCT00248989 | Nov 2004 → Nov 2005 | skin atrophy | CHU de Quebec-Universite Laval | Completed | No outcome recorded |
| Phase 3 | NCT00082511 | Jul 2003 → Aug 2005 | systemic lupus erythematosus | Genelabs Technologies | Completed | Mixed |
| Phase 3 | NCT00053560 | Dec 2002 → Aug 2004 | systemic lupus erythematosus | Genelabs Technologies | Unknown | Mixed |
| Phase 3 | NCT00182975 | Sep 2002 → Sep 2007 | — | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 3 | NCT00442403 | Apr → Sep 2002 | Plasmodium falciparum malaria | Université Victor Segalen Bordeaux 2 | Suspended | No outcome recorded |
| Phase 3 | NCT00205686 | Apr 2001 → Sep 2005 | — | Washington University School of Medicine | Completed | Met primary |
| Phase 3 | NCT00004662 | Mar 1996 → ? | systemic lupus erythematosus | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 3 | NCT00004313 | Aug 1995 → ? | primary adrenal insufficiency | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04705883 | Sep 2020 → Nov 2021 | breast cancer, postmenopausal atrophic vaginitis | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT03568604 | Aug 2018 → Jan 2020 | — | San Diego Sexual Medicine | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT07854873 | Oct 2022 → Jan 2026 | female stress incontinence, pelvic organ prolapse | Poznan University of Medical Sciences | Completed | No outcome recorded |
| — | NCT05246865 | Oct 2021 → Dec 2022 | polycystic ovary syndrome | University of Birmingham | Unknown | No outcome recorded |
| — | NCT02432248 | Feb 2015 → Dec 2023 | infertility disorder | The Affiliated Hospital of Inner Mongolia Medical University | Unknown | No outcome recorded |
| — | NCT01145144 | Jan 2008 → Jul 2009 | ovarian hyperstimulation syndrome | Meir Medical Center | Completed | No outcome recorded |
| — | NCT00471900 | Oct 2001 → Feb 2003 | adrenocortical insufficiency | University of Aarhus | Completed | No outcome recorded |
| — | NCT00099697 | Jun 2001 → Feb 2004 | obesity disorder | National Institute on Aging (NIA) | Completed | Mixed |
| — | NCT00111930 | Aug 2000 → Mar 2005 | — | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 0 | NCT03228732 Comparator | Dec 2017 → Sep 2026 overdue | type 1 diabetes mellitus | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| 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 1/2 | NCT07535983 Background | Sep 2025 → Jan 2027 expected | ovarian dysfunction | Jiangxi University of Traditional Chinese Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT05935761 Comparator | Dec 2026 → Oct 2029 expected | chronic pain syndrome | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| 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 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 Stop: Business |
| 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 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 |
| — | NCT07574216 Comparator | Aug 2026 → Dec 2031 expected | physiological sexual disorder, postmenopausal atrophic vaginitis | University of Arizona | Recruiting | No outcome recorded |
| — | NCT00916396 Comparator | Jun 2005 → Jan 2011 | hypoactive sexual desire disorder | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-03-09 | Lupin Limited | Lupin Pharma Canada Announces Partnership with Endoceutics for the commercialization of Intrarosa® lupin.com ↗ |
Evidence & citations 13 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 201653“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 “Furthermore, dehydroepiandrosterone (DHEA) is another neurosteroid that has been implicated in pain.” NCT05935761 ↗ |
| Known as | BAY86-5314 | “Dehydroepiandrosterone, BAY86-5314” NCT00566384 ↗ |
| 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 ↗46“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) will be administered orally at a fixed dose of 100 mg/day for 6 weeks as add-on treatment to continued standard antidepressant monotherapy.” NCT07843927 ↗ “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 |
| 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 ↗4“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 201619“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 ↗ |