MedPath

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

Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women

Phase 3
Withdrawn
Conditions
Recurrent Urinary Tract Infection
Postmenopause
Postmenopausal Syndrome
Postmenopausal Symptoms
Menopause
Interventions
Drug: Placebo
First Posted Date
2019-02-26
Last Posted Date
2021-06-30
Lead Sponsor
Olivia Cardenas-Trowers, M.D.
Registration Number
NCT03854396
Locations
🇺🇸

University of Louisville Urogynecology at Springs Medical Center, Louisville, Kentucky, United States

Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy

Phase 3
Conditions
Menopause Syndrome
Dyspareunia
Menopause
Genitourinary Syndrome of Menopause
Vulvovaginal Atrophy
Interventions
Drug: Placebos
First Posted Date
2018-12-20
Last Posted Date
2019-01-31
Lead Sponsor
Center for Vulvovaginal Disorders
Target Recruit Count
40
Registration Number
NCT03782480
Locations
🇺🇸

The Centers for Vulvovaginal Disorders, New York, New York, United States

Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer

Phase 3
Withdrawn
Conditions
Vaginal Atrophy in Breast Cancer Patients
Interventions
First Posted Date
2018-11-14
Last Posted Date
2020-07-31
Lead Sponsor
EndoCeutics Inc.
Registration Number
NCT03740945

Effects of DHEA in Pulmonary Hypertension

Phase 2
Active, not recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
Other: Placebo
First Posted Date
2018-08-27
Last Posted Date
2024-11-22
Lead Sponsor
Rhode Island Hospital
Target Recruit Count
24
Registration Number
NCT03648385
Locations
🇺🇸

Rhode Island Hospital Pulmonary Hypertension Center, Providence, Rhode Island, United States

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

Phase 3
Withdrawn
Conditions
Hypoactive Sexual Desire Disorder (HSDD)
Interventions
First Posted Date
2018-08-07
Last Posted Date
2020-07-31
Lead Sponsor
EndoCeutics Inc.
Registration Number
NCT03619005
Locations
🇺🇸

Endoceutics site # 91, Savannah, Georgia, United States

🇺🇸

Endoceutics site # 20, New York, New York, United States

🇺🇸

Endoceutics site # 106, Huntsville, Alabama, United States

and more 7 locations

Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

Phase 4
Completed
Conditions
Dyspareunia
Interventions
First Posted Date
2018-06-26
Last Posted Date
2022-06-09
Lead Sponsor
San Diego Sexual Medicine
Target Recruit Count
18
Registration Number
NCT03568604
Locations
🇺🇸

San Diego Sexual Medicine, San Diego, California, United States

Neurosteroids in PTSD - Biomarkers to Therapeutics

Phase 2
Terminated
Conditions
Posttraumatic Stress Disorder
Interventions
First Posted Date
2018-04-06
Last Posted Date
2023-05-06
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
5
Registration Number
NCT03491007
Locations
🇺🇸

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

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

Phase 3
Completed
Conditions
Hypoactive Sexual Desire Disorder
Interventions
First Posted Date
2017-09-19
Last Posted Date
2021-04-09
Lead Sponsor
EndoCeutics Inc.
Target Recruit Count
653
Registration Number
NCT03287232
Locations
🇺🇸

Endoceutics site # 106, Huntsville, Alabama, United States

🇺🇸

Endoceutics site # 104, Mobile, Alabama, United States

🇺🇸

Endoceutics site # 108, Berkeley, California, United States

and more 66 locations

The Effects of Fluoxetine And/or DHEA

Early Phase 1
Recruiting
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2017-07-25
Last Posted Date
2024-11-05
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
60
Registration Number
NCT03228732
Locations
🇺🇸

University of Maryland, Baltimore, Maryland, United States

Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles

Phase 4
Completed
Conditions
Infertility
Interventions
First Posted Date
2016-08-15
Last Posted Date
2019-09-19
Lead Sponsor
ShangHai Ji Ai Genetics & IVF Institute
Target Recruit Count
78
Registration Number
NCT02866253
© Copyright 2025. All Rights Reserved by MedPath