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Prasterone

Generic Name
Prasterone
Brand Names
Intrarosa
Drug Type
Small Molecule
Chemical Formula
C19H28O2
CAS Number
53-43-0
Unique Ingredient Identifier
459AG36T1B
Background

Prasterone, also known as dehydroepiandrosterone (DHEA) is a major C19 steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Dehydroepiandrosterone (DHEA) can be converted to testosterone; androstenedione; estradiol; and estrone. Most of DHEA is sulfated (dehydroepiandrosterone sulfate) before secretion.

In the United States, DHEA or DHEAS have been advertised with claims that they may be beneficial for a wide variety of ailments. DHEA and DHEAS are readily available in the United States, where they are marketed as over-the-counter dietary supplements. In November 2016, DHEA was approved (as Intrarosa) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

In Canada, a prescription is required to buy DHEA.

Indication

DHEA is taken as a supplement for a variety of unsubstantiated indications. The following indications have shown promise and are backed up by some scientific evidence: schizophrenia (DHEA may be more effective in women than men); improving the appearance of older people’s skin (taking DHEA by mouth seems to increase skin thickness and moisture, and decrease facial “age spots” in elderly men and women); improving ability to achieve an erection in men with sexual dysfunction. Additionally, DHEA has shown promise in improving symptoms of lupus (SLE). Taking DHEA by mouth along with conventional treatment may help reduce the number of times symptoms flare up and may allow a reduction in the dose of prescription drugs needed. DHEA may also help SLE symptoms such as muscle ache and mouth ulcers. DHEA also seems to strengthen bones in SLE patients being treated with high-dose steroids (corticosteroids).

DHEA also shows promise in the treatment of osteoporosis. Taking DHEA by mouth daily seems to improve bone mineral density (BMD) in older women and men with osteoporosis or osteopenia (pre-osteoporosis). DHEA may also increase BMD in young women with the eating disorder called anorexia nervosa. DHEA is often prescribed in India for the induction of ovulation to improve chances of pregnancy.

Associated Conditions
Moderate Dyspareunia, Severe Dyspareunia

Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer

Phase 3
Not yet recruiting
Conditions
Women With Breast Cancer
Interventions
First Posted Date
2024-09-25
Last Posted Date
2024-11-19
Lead Sponsor
European Institute of Oncology
Target Recruit Count
95
Registration Number
NCT06611514
Locations
🇮🇹

European Institute of Oncology, Milan, Italy

Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial

Phase 2
Not yet recruiting
Conditions
Chronic Low Back Pain
Interventions
First Posted Date
2023-07-07
Last Posted Date
2025-01-14
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
108
Registration Number
NCT05935761
Locations
🇺🇸

Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States

The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders

Phase 2
Not yet recruiting
Conditions
Poor Responders
Interventions
First Posted Date
2023-06-12
Last Posted Date
2023-07-18
Lead Sponsor
Beni-Suef University
Target Recruit Count
300
Registration Number
NCT05900661
Locations
🇪🇬

Beni-suef university Hospital, Banī Suwayf, Beni Suef, Egypt

GRACE-trial: a Randomized Active-controlled Trial for VulvovaGinal AtRophy in BreAst Cancer Patients on Endocrine Therapy.

Phase 4
Active, not recruiting
Conditions
Vulvovaginal Atrophy
Breast Cancer
Interventions
Drug: Estrogen + probiotics
Drug: Moisturizer
First Posted Date
2022-09-30
Last Posted Date
2025-03-04
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
160
Registration Number
NCT05562518
Locations
🇧🇪

University Hospital Ghent, Gent, Belgium

Impact of 11-oxygenated Androgens on Metabolic Dysfunction of Women With Polycystic Ovary Syndrome

Not Applicable
Recruiting
Conditions
Polycystic Ovary Syndrome
Interventions
First Posted Date
2022-02-18
Last Posted Date
2022-11-02
Lead Sponsor
University of Birmingham
Target Recruit Count
100
Registration Number
NCT05246865
Locations
🇬🇧

Institute of Metabolism and Systems Research, Birmingham, West Midlands, United Kingdom

Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain

Phase 3
Conditions
Vulvovaginal Atrophy
Interventions
First Posted Date
2021-05-24
Last Posted Date
2021-06-02
Lead Sponsor
Dr. Santiago Palacios
Target Recruit Count
50
Registration Number
NCT04898556
Locations
🇪🇸

Instituto Palacios, Madrid, Spain

Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

Phase 4
Completed
Conditions
Genitourinary Syndrome of Menopause
Vulvar Atrophy
Breast Cancer
Interventions
First Posted Date
2021-01-12
Last Posted Date
2022-02-22
Lead Sponsor
Hospital Clinic of Barcelona
Target Recruit Count
10
Registration Number
NCT04705883
Locations
🇪🇸

Hospital Clínic de Barcelona, Barcelona, Spain

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors

Phase 2
Terminated
Conditions
Long-term Survivors
Postmenopausal Symptoms
Breast Cancer Female
Vaginal Atrophy
Interventions
Combination Product: Vaginal Polycarbophil Moisturizer
First Posted Date
2020-07-30
Last Posted Date
2024-11-27
Lead Sponsor
University of Arkansas
Target Recruit Count
8
Registration Number
NCT04493333
Locations
🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Does DHEA IVF Outcomes in Poor Responders?

Phase 2
Suspended
Conditions
Poor Response to Ovulation Induction
Infertility, Female
Interventions
First Posted Date
2019-08-26
Last Posted Date
2022-06-23
Lead Sponsor
Homerton University Hospital NHS Foundation Trust
Target Recruit Count
400
Registration Number
NCT04066478
Locations
🇬🇧

Homerton Fertility Centre, London, United Kingdom

Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)

First Posted Date
2019-05-30
Last Posted Date
2019-05-30
Lead Sponsor
Laboratorios Andromaco S.A.
Target Recruit Count
46
Registration Number
NCT03967964
Locations
🇨🇱

Instituto de Investigación Materno Infantil (IDIMI) - Maternidad Hospital San Borja (HCSBA), Santiago, Chile

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