Overview
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 Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/25 | Phase 3 | Not yet recruiting | European Institute of Oncology | ||
2023/07/07 | Phase 2 | Not yet recruiting | |||
2023/06/12 | Phase 2 | Not yet recruiting | |||
2022/09/30 | Phase 4 | Active, not recruiting | |||
2022/02/18 | Not Applicable | Recruiting | |||
2021/05/24 | Phase 3 | UNKNOWN | Dr. Santiago Palacios | ||
2021/01/12 | Phase 4 | Completed | |||
2020/07/30 | Phase 2 | Terminated | |||
2019/08/26 | Phase 2 | Suspended | Homerton University Hospital NHS Foundation Trust | ||
2019/05/30 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Millicent US, Inc. | 72495-401 | VAGINAL | 6.5 mg in 1 1 | 1/17/2023 | |
| Millicent US, Inc. | 72495-501 | VAGINAL | 6.5 mg in 1 1 | 1/17/2023 | |
| SHYNE BRANDS/BIOLabs PRO | 82018-0028 | TRANSDERMAL | 1000 mg in 102 g | 6/1/2025 | |
| AMAG Pharmaceuticals, Inc. | 64011-601 | VAGINAL | 6.5 mg in 1 1 | 6/20/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/8/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sodium Prasterone Sulfate for Injection | 国药准字H10960259 | 化学药品 | 注射剂(冻干) | 8/3/2020 | |
| Sodium Prasterone Sulfate for Injection | 国药准字H10940064 | 化学药品 | 注射剂 | 8/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| INTRAROSA prasterone 6.5 mg pessary blister pack | 391550 | Medicine | A | 6/16/2023 |
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