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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

Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults

Phase 2
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Hypertension, Pulmonary
Interventions
First Posted Date
2011-01-10
Last Posted Date
2022-02-09
Lead Sponsor
University Hospital, Bordeaux
Target Recruit Count
51
Registration Number
NCT01273259
Locations
🇫🇷

CHU de Strasbourg, Strasbourg, France

🇫🇷

CHU de Limoges, Limoges, France

🇫🇷

CHU de Toulouse, Toulouse, France

and more 1 locations

DHEA Against Vaginal Atrophy - Safety Study of 12 Months

Phase 3
Completed
Conditions
Vaginal Atrophy
Interventions
First Posted Date
2010-12-08
Last Posted Date
2017-10-18
Lead Sponsor
EndoCeutics Inc.
Target Recruit Count
530
Registration Number
NCT01256671
Locations
🇺🇸

EndoCeutics site # 25, Lincoln, Nebraska, United States

🇺🇸

EndoCeutics site # 09, West Jordan, Utah, United States

🇨🇦

EndoCeutics site # 13, Calgary, Alberta, Canada

and more 38 locations

DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Phase 3
Completed
Conditions
Vaginal Atrophy
Interventions
Drug: Placebo
First Posted Date
2010-12-08
Last Posted Date
2017-06-26
Lead Sponsor
EndoCeutics Inc.
Target Recruit Count
255
Registration Number
NCT01256684
Locations
🇺🇸

EndoCeutics site # 21, Sacramento, California, United States

🇺🇸

EndoCeutics site # 22, Kalamazoo, Michigan, United States

🇺🇸

EndoCeutics site # 10, Meridian, Idaho, United States

and more 30 locations

Dehydroepiandrosterone Supplementation for Poor Responder Patients During in Vitro Fertilization Treatment

Not Applicable
Completed
Conditions
Ovarian Stimulation
Interventions
First Posted Date
2010-06-16
Last Posted Date
2010-06-16
Lead Sponsor
Meir Medical Center
Registration Number
NCT01145144
Locations
🇮🇱

Meir Medical center IVF unit, kfar Saba, Israel

🇮🇱

Meir Medical Center, Kfar Sava, Israel

The Use of DHEA in Women With Premature Ovarian Failure

Early Phase 1
Withdrawn
Conditions
Premature Ovarian Failure
Interventions
First Posted Date
2010-05-25
Last Posted Date
2013-01-29
Lead Sponsor
Virginia Center for Reproductive Medicine
Registration Number
NCT01129947
Locations
🇺🇸

Virginia Center for Reproductive Medicine, Reston, Virginia, United States

DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

Phase 1
Terminated
Conditions
Breast Cancer
Interventions
Procedure: Surgical resection
First Posted Date
2009-09-04
Last Posted Date
2019-09-17
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Target Recruit Count
1
Registration Number
NCT00972023
Locations
🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder

Not Applicable
Conditions
Hypoactive Sexual Desire Disorder
Interventions
First Posted Date
2009-06-09
Last Posted Date
2009-12-01
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Target Recruit Count
50
Registration Number
NCT00916396
Locations
🇮🇱

Tel Aviv Aviv Medical Center, Tel Aviv, Israel

Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Early Phase 1
Completed
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2008-02-06
Last Posted Date
2019-09-12
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
50
Registration Number
NCT00607646
Locations
🇺🇸

University of Maryland, Baltimore, Baltimore, Maryland, United States

Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults

Phase 3
Conditions
Hypertension, Pulmonary
Chronic Obstructive Pulmonary Disease
Interventions
First Posted Date
2007-12-27
Last Posted Date
2015-01-14
Lead Sponsor
University Hospital, Bordeaux
Target Recruit Count
60
Registration Number
NCT00581087
Locations
🇫🇷

University Hospital, Strasbourg, Strasbourg, France

🇫🇷

University Hospital, Toulouse, Toulouse, France

🇫🇷

University Hospital, Bordeaux, Bordeaux, France

and more 2 locations

Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency

Phase 3
Completed
Conditions
Adrenal Insufficiency
Interventions
First Posted Date
2007-12-18
Last Posted Date
2007-12-18
Lead Sponsor
University Hospital Tuebingen
Target Recruit Count
23
Registration Number
NCT00575341
Locations
🇩🇪

Universitaetskinik für Kinder und Jugendliche, Erlangen, Bayern, Germany

🇩🇪

Universitaetsklinik und Poliklinik für Kinder und Jungendliche, Leipzig, Sachsen, Germany

🇩🇪

Universitaere Kinderklinik, Heidelberg, Baden-Wuerttemberg, Germany

and more 1 locations
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