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

Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria

Completed
Conditions
Infertility
Interventions
First Posted Date
2014-05-07
Last Posted Date
2014-05-07
Lead Sponsor
Chinese Medical Association
Target Recruit Count
386
Registration Number
NCT02132559
Locations
🇨🇳

Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

Phase 3
Completed
Conditions
Vaginal Atrophy
Interventions
First Posted Date
2013-12-17
Last Posted Date
2017-06-01
Lead Sponsor
EndoCeutics Inc.
Target Recruit Count
558
Registration Number
NCT02013544
Locations
🇨🇦

EndoCeutics site # 69, Corunna, Ontario, Canada

🇨🇦

EndoCeutics site # 77, Quebec City, Quebec, Canada

🇨🇦

EndoCeutics site # 04, Drummondville, Quebec, Canada

and more 35 locations

A Phase II Study Evaluating the Role of Androgen Receptors as Targets for Therapy of Pre-treated Post-menopausal Patients With ER/PgR-negative/AR-positive or ER and/or PgRpositive/ AR-positive Metastatic Breast Cancer (ARTT)

Phase 2
Terminated
Conditions
Metastatic Breastcancer
Estrogen Receptor Negative Neoplasm
Estrogen Receptor Positive Breast Cancer
Progesterone Receptor Positive Tumor
Progesterone Receptor Negative Neoplasm
Androgen Receptor Gene Overexpression
Interventions
First Posted Date
2013-12-04
Last Posted Date
2016-09-29
Lead Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Target Recruit Count
20
Registration Number
NCT02000375
Locations
🇮🇹

Oncologia medica PO Ravenna AUSL della Romagna, Ravenna, RA, Italy

🇮🇹

Oncologia Medica PO Lugo, AUSL della Romagna, Lugo, RA, Italy

🇮🇹

Oncologia medica , PO FAENZA, Ausl della Romagna, Faenza, RA, Italy

and more 5 locations

7-Keto DHEA for the Treatment of PTSD

Phase 2
Completed
Conditions
PTSD
Interventions
First Posted Date
2013-05-24
Last Posted Date
2015-10-29
Lead Sponsor
Humanetics Corporation
Target Recruit Count
71
Registration Number
NCT01861847
Locations
🇺🇸

Bay Pines VA Healthcare System, Bay Pines, Florida, United States

Topical DHEA Against Vaginal Atrophy

Phase 3
Completed
Conditions
Vaginal Atrophy
Interventions
First Posted Date
2013-05-03
Last Posted Date
2017-08-29
Lead Sponsor
EndoCeutics Inc.
Target Recruit Count
218
Registration Number
NCT01846442
Locations
🇺🇸

EndoCeutics site # 05, Cleveland, Ohio, United States

🇺🇸

EndoCeutics site # 03, Norfolk, Virginia, United States

🇨🇦

EndoCeutics site # 10, Montreal, Quebec, Canada

and more 5 locations

Vaginal DHEA for Women After Breast Cancer

Phase 2
Withdrawn
Conditions
Vaginal Dryness
Breast Cancer
Urinary Incontinence
Quality of Life
Sexual Satisfaction
Interventions
Drug: Placebo
First Posted Date
2012-11-09
Last Posted Date
2017-11-28
Lead Sponsor
Hadassah Medical Organization
Registration Number
NCT01724242
Locations
🇮🇱

Hadassah Medical Organization, Jerusalem, Israel

Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

Phase 3
Completed
Conditions
Infertility
Ovarian Aging
Diminished Ovarian Reserve (DOR)
Predicted Poor-responders
Interventions
First Posted Date
2012-04-05
Last Posted Date
2015-12-09
Lead Sponsor
University of Nottingham
Target Recruit Count
60
Registration Number
NCT01572025
Locations
🇬🇧

Nottingham University Research and Treatment Unit in Reproduction (NURTURE), Nottingham, Nottinghamshire, United Kingdom

Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women

Phase 3
Completed
Conditions
Vasomotor Symptoms
Hot Flushes
Interventions
First Posted Date
2011-10-14
Last Posted Date
2013-12-11
Lead Sponsor
EndoCeutics Inc.
Target Recruit Count
238
Registration Number
NCT01452373
Locations
🇨🇦

EndoCeutics site # 04, Drummondville, Quebec, Canada

🇨🇦

EndoCeutics site # 69, Corunna, Ontario, Canada

🇨🇦

EndoCeutics site # 71, London, Ontario, Canada

and more 12 locations

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms

Phase 3
Completed
Conditions
Breast Cancer
Gynecologic Cancer
Interventions
Other: placebo
First Posted Date
2011-06-20
Last Posted Date
2019-02-07
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
464
Registration Number
NCT01376349
Locations
🇺🇸

St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States

🇺🇸

Illinois CancerCare - Macomb, Macomb, Illinois, United States

🇺🇸

Elkhart Clinic, LLC, Elkhart, Indiana, United States

and more 274 locations

Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

Phase 3
Completed
Conditions
Vaginal Atrophy
Interventions
Drug: Placebo
First Posted Date
2011-05-24
Last Posted Date
2017-06-12
Lead Sponsor
EndoCeutics Inc.
Target Recruit Count
450
Registration Number
NCT01358760
Locations
🇺🇸

EndoCeutics site # 66, Danbury, Connecticut, United States

🇺🇸

EndoCeutics site # 27, Baltimore, Maryland, United States

🇺🇸

EndoCeutics site # 15, Columbus, Ohio, United States

and more 39 locations
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