Prasterone

Mechanism-of-action classes: Mechanism of Action; Unknown Cellular or Molecular Interaction.

• INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.ICD-10: N95.1

• Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding.contraindicated

Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime. ( 2 )

Current or Past History of Breast Cancer. ( 5.1 ) 5.1 Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.

In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. ( 6.1 ) In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Millicent U.S. Inc at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In four (4) placebo-controlled, 12-week clinical trials [91% - White Caucasian non-Hispanic women, 7% - Black or African American women, and 2% - "Other" women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group. There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group.

8.1 Pregnancy Risk Summary INTRAROSA is indicated only in postmenopausal women. There are no data with INTRAROSA use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with prasterone. 8.2 Lactation Risk Summary INTRAROSA is indicated only in postmenopausal women. There is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production. 8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients. 8.5 Geriatric Use Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older. 8.6 Renal Impairment The effect of renal impairment on the pharmacokinetics of prasterone has not been studied. 8.7 Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of prasterone has not been studied.

• Nov 16, 2016NDANDA208470Millicent

1. 1Off Label Use78130%
2. 2Headache1636.3%
3. 3Drug Ineffective1596.1%
4. 4Fatigue1566.0%
5. 5Nausea1234.7%
6. 6Product Dose Omission Issue1204.6%
7. 7Application Site Discharge1144.4%
8. 8Insomnia923.5%
9. 9Rash913.5%
10. 10Dizziness883.4%
11. 11Pain873.3%
12. 12Vaginal Discharge843.2%
13. 13Alopecia793.0%
14. 14Vulvovaginal Burning Sensation783.0%
15. 15Pruritus773.0%

Recent PubMed references pinned to Prasterone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The sex-specific role of adrenal androgens in youth psychopathology.
  Translational psychiatry · 2026 · Weisner FE, Serio B, Valk S, et al.
  PMID 42243081DOI 10.1038/s41398-026-04121-3
• Chemical and Microbiological Stability Supporting Extended BUDs in Pentravan® Based Transdermal Preparations.
  International journal of pharmaceutical compounding · 2026 · Polonini H, Kegele CS, Marianni B, et al.
  PMID 42143785
• Dehydroepiandrosterone (DHEA) as a tool for conservation.
  Environmental monitoring and assessment · 2026 · Fokidis HB
  PMID 42126737DOI 10.1007/s10661-026-15408-9
• The effect of dehydroepiandrosterone on the vascular system: role of H(2)S/NO pathways.
  European journal of pharmacology · 2026 · Turnaturi C, Indolfi C, Correale M, et al.
  PMID 42114734DOI 10.1016/j.ejphar.2026.178957
• Immune checkpoint blockade as an accelerator of adrenal aging: a testable model linking low-grade cortical inflammation to proteostasis failure, LDLR/SULT2A1 suppression, and reduced DHEA output.
  Journal for immunotherapy of cancer · 2026 · Ding G, Xu Y, Guo T, et al.
  PMID 42044975DOI 10.1136/jitc-2025-014454
• Puerarin and DHEA combination therapy alleviates primary dysmenorrhea via inhibition of the Hsp90ab1/p38/JNK pathway.
  Molecular immunology · 2026 · Zhu Z, Ruan J, Wang R, et al.
  PMID 42030694DOI 10.1016/j.molimm.2026.04.011
• Adrenal Biomarkers of Stress in Transgender and Gender-Diverse Adolescents.
  Developmental psychobiology · 2026 · Coslovich S, Tonetto S, Bragato G, et al.
  PMID 42003202DOI 10.1002/dev.70156
• Low serum dehydroepiandrosterone sulfate is related to diabetic retinopathy in males with type 2 diabetes mellitus.
  Journal of translational medicine · 2026 · Li S, Zhu C, Jiang F, et al.
  PMID 41992237DOI 10.1186/s12967-026-08121-1

The 10 most recently updated of 137 ClinicalTrials.gov registrations naming Prasterone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults (DHEA-HTAP)
  Completed · Phase 2 · Interventional · 51 enrolled · University Hospital, Bordeaux
  NCT01273259updated 2026-06-11
• Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
  Completed · Phase 3 · Interventional · 60 enrolled · University Hospital, Bordeaux
  NCT00581087updated 2026-06-10
• Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial
  Not yet recruiting · Phase 2 · Interventional · 108 enrolled · VA Office of Research and Development
  NCT05935761updated 2026-06-04
• A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline
  Recruiting · Phase 1 · Phase 2 · Interventional · 74 enrolled · Jiangxi University of Traditional Chinese Medicine
  NCT07535983updated 2026-06-03
• Impact of Prasterone on Cardiometabolic Indicators in Perimenopausal Women.
  Completed · Phase 3 · Interventional · 25 enrolled · Universidad de Guanajuato
  NCT07609043updated 2026-05-27
• Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
  Active not recruiting · Interventional · 70 enrolled · Boston Children's Hospital
  NCT04488757updated 2026-05-22
• Combination Osilodrostat and Cabergoline in Cushing's Disease
  Enrolling by invitation · Phase 4 · Interventional · 50 enrolled · University of Basrah
  NCT07603466updated 2026-05-22
• VEDA Study (DHEA vs Estradiol)
  Not yet recruiting · Interventional · 324 enrolled · University of Arizona
  NCT07574216updated 2026-05-07
• GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.
  Active not recruiting · Phase 4 · Interventional · 160 enrolled · University Hospital, Ghent
  NCT05562518updated 2026-04-30
• Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer
  Recruiting · Phase 2 · Interventional · 25 enrolled · Ohio State University Comprehensive Cancer Center
  NCT07407647updated 2026-04-21

Frequently asked questions

How does Prasterone work?

Mechanism-of-action classes: Mechanism of Action; Unknown Cellular or Molecular Interaction.

What is Prasterone used for?

According to FDA labeling, Prasterone carries indications including: INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Prasterone?

Prasterone is classified as Androstan derivatives, Other sex hormones and modulators of the genital system, Mechanism of Action, Unknown Cellular or Molecular Interaction, Adrenal Medullary Activity Alteration, Enhance Penile Erection, Increased Ovarian Estrogen Secretion, Increased Testosterone Secretion.

What are the brand names for Prasterone?

Prasterone is marketed under brand names including Intrarosa.

What are the contraindications for Prasterone?

Prasterone labeling lists contraindications including: Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding.. Always consult the full prescribing information and a clinician.