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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Dhea
Generic Name
Dhea (dehydroepiandrosterone)
Active Ingredient
PrasteroneCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 6 [hp_X]/mL | LIQUID | ORAL | 43742-0564 |
Detailed information about Dhea
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Dhea, you must consult a qualified healthcare professional.
Prasterone, also known as dehydroepiandrosterone (DHEA), is a synthetic steroid precursor used primarily as a vaginal insert to treat moderate to severe dyspareunia (painful intercourse) caused by vulvovaginal atrophy in postmenopausal women.
For the treatment of moderate to severe dyspareunia associated with vulvovaginal atrophy:
Prasterone is not indicated for use in the pediatric population. It is specifically designed for postmenopausal women. There is no clinical data regarding the safety or efficacy of prasterone in children or adolescents, and its hormonal nature could potentially interfere with normal growth and development in younger individuals.
The effect of renal (kidney) impairment on the pharmacokinetics of prasterone has not been formally studied. However, because the dose is low and the primary action is local, dosage adjustments are generally not expected to be necessary for patients with mild to moderate renal impairment. Use with caution in severe renal disease.
Prasterone is metabolized in the liver. While systemic levels remain low with vaginal administration, patients with significant hepatic (liver) impairment should be monitored closely, as the body's ability to clear metabolites may be reduced.
No specific dosage adjustments are required for elderly patients. Clinical trials for prasterone included a significant number of women over the age of 65, and no overall differences in safety or effectiveness were observed compared to younger postmenopausal women.
Proper administration is crucial for the effectiveness of prasterone. Patients should follow these steps:
If you miss a dose of prasterone:
Because prasterone is administered as a local vaginal insert with low systemic absorption, an acute overdose is unlikely to cause life-threatening symptoms. However, excessive use may lead to increased systemic levels of androgens and estrogens, potentially causing symptoms such as breast tenderness, mood swings, or acne. In the event of accidental ingestion or suspected overdose, contact a poison control center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or frequency of use without medical guidance, as this may affect the safety and efficacy of the treatment.
The most frequently reported side effect in clinical trials for prasterone vaginal inserts is:
In clinical studies, the following side effects were reported by 1% to 10% of users:
Rare but possible side effects may include:
> Warning: Stop taking Prasterone and call your doctor immediately if you experience any of these serious symptoms:
Long-term safety data for prasterone (up to 52 weeks in clinical trials) suggests that the risk of endometrial thickening (overgrowth of the uterine lining) is very low. However, because prasterone is converted into estrogens and androgens, the long-term effects on breast tissue and the cardiovascular system are still being monitored. Unlike systemic HRT, prasterone does not appear to significantly alter systemic lipid profiles or coagulation factors over a one-year period.
There are currently no FDA black box warnings for prasterone (Intrarosa). However, the labeling does include precautions regarding its use in women with a history of breast cancer, as the metabolic products (estrogens and androgens) could theoretically stimulate the growth of hormone-sensitive tumors.
Report any unusual or persistent symptoms to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.
Prasterone is a hormonal precursor. While its primary action is intended to be local within the vaginal tissue, it is not entirely free from systemic considerations. Patients should be aware that prasterone is metabolized into active sex hormones, which can influence various physiological systems. It is not a lubricant; it is a medication that changes the structure and function of the vaginal lining.
No FDA black box warnings for Prasterone. Unlike some systemic estrogen therapies, prasterone has not been required to carry boxed warnings regarding cardiovascular risks or endometrial cancer, largely due to its localized intracrine mechanism and the low doses used.
Patients using prasterone should undergo regular medical follow-ups, typically including:
Prasterone is not known to cause drowsiness, dizziness, or cognitive impairment. It is considered safe to drive or operate heavy machinery while using this medication.
There are no known direct interactions between alcohol and prasterone vaginal inserts. However, excessive alcohol consumption can affect overall hormonal balance and bone health in postmenopausal women.
If you stop using prasterone, the symptoms of vulvovaginal atrophy (such as dryness and painful intercourse) are likely to return over time as the vaginal tissue reverts to its postmenopausal state. There is no known withdrawal syndrome associated with stopping prasterone, and tapering the dose is generally not required.
> Important: Discuss all your medical conditions, especially any history of cancer or blood clots, with your healthcare provider before starting Prasterone.
While there are no absolute contraindications listed for specific drug-drug interactions in the FDA label, the following should be avoided due to conflicting mechanisms:
There are no known interactions between prasterone vaginal inserts and specific foods. Because the drug is administered vaginally and acts locally, its absorption is not affected by the presence of food in the digestive tract.
Prasterone use may affect certain laboratory results:
For each major interaction, the primary concern is the potential for prasterone to provide the "fuel" (precursors) for hormone production that other medications are trying to suppress. Management usually involves avoiding the combination or performing more frequent monitoring of the underlying condition.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, especially any hormonal therapies.
Prasterone must NEVER be used in the following circumstances:
Conditions requiring a careful risk-benefit analysis by a healthcare provider include:
There is little evidence of cross-sensitivity between prasterone and other non-steroidal medications. However, individuals sensitive to other steroid hormones (like testosterone or estrogen) should be monitored for similar adverse reactions. Additionally, those with allergies to coconut oil or palm kernel oil derivatives should check the inactive ingredients, as the hard fat base may be derived from these sources.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of cancer or liver disease, before prescribing Prasterone.
Prasterone is not indicated for use in pregnant women. According to FDA standards, it is essentially contraindicated in pregnancy (formerly Category X). There is no clinical need for prasterone during pregnancy, and exposure to exogenous androgens and estrogens can interfere with the normal hormonal environment necessary for fetal development. If pregnancy occurs while using prasterone, the medication should be discontinued immediately.
Prasterone is not indicated for use in nursing mothers. It is not known whether prasterone or its metabolites are excreted in human milk. However, because of the potential for serious adverse reactions in a nursing infant from exposure to sex hormones, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established. Prasterone is specifically intended for use in postmenopausal women. The use of steroid precursors in children could lead to premature epiphyseal closure (stopping bone growth) and precocious puberty.
In clinical trials of prasterone, a significant percentage of participants were aged 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger postmenopausal subjects. Prasterone is a mainstay of treatment for VVA in the geriatric population, as the prevalence of dyspareunia increases with the time elapsed since menopause.
Specific studies in patients with renal impairment have not been conducted. However, since the 6.5 mg dose is administered locally and systemic absorption is minimal, renal impairment is not expected to significantly alter the clinical effect or safety profile. No dose adjustment is currently recommended for mild to moderate renal dysfunction.
No studies have been performed in patients with hepatic impairment. Because the liver is the primary site for the metabolism of steroid hormones, patients with severe hepatic impairment should be monitored closely. In such patients, the clearance of any systemically absorbed prasterone or its metabolites might be reduced, potentially leading to higher systemic levels.
> Important: Special populations, particularly those with a history of hormone-sensitive cancers, require individualized medical assessment and frequent monitoring.
Prasterone (DHEA) acts as a pro-hormone. Its molecular mechanism is based on the concept of intracrinology. After vaginal administration, prasterone enters the vaginal cells (epithelial cells, fibroblasts, and smooth muscle cells). Inside these cells, it is converted by intracellular enzymes (such as 3β-HSD, 17β-HSD, and aromatase) into active androgens and estrogens.
The primary pharmacodynamic effect of prasterone is the improvement of the vaginal maturation index (increasing the percentage of superficial cells and decreasing parabasal cells) and the lowering of vaginal pH. These changes usually begin within the first 2 weeks of treatment, with maximal effects observed by 12 weeks. Unlike systemic estrogens, prasterone at the 6.5 mg dose does not typically cause significant proliferation of the endometrium.
| Parameter | Value |
|---|---|
| Bioavailability | Low systemic bioavailability (primarily local action) |
| Protein Binding | ~95% (primarily to Albumin and SHBG) |
| Half-life | ~15-20 hours (for DHEA-S metabolite) |
| Tmax | 1.0 to 4.0 hours (post-vaginal administration) |
| Metabolism | Intracellular conversion; Hepatic sulfation/glucuronidation |
| Excretion | Primarily Renal (as metabolites) |
Prasterone is classified as a steroid precursor and a vaginal hormone replacement therapy. It is unique among VVA treatments because it provides both estrogenic and androgenic precursors, whereas most other treatments are exclusively estrogenic.
Common questions about Dhea
Prasterone is primarily used to treat moderate to severe dyspareunia, which is the medical term for painful sexual intercourse. This condition is a common symptom of vulvovaginal atrophy, which occurs in postmenopausal women due to declining estrogen levels. By providing a precursor that the body converts into estrogens and androgens locally in the vaginal tissues, prasterone helps restore the health of the vaginal lining. This restoration leads to increased lubrication, thicker vaginal walls, and a more balanced pH, all of which contribute to reducing pain during intercourse. It is specifically intended for women who have already gone through menopause.
The most common side effect reported by women using prasterone vaginal inserts is vaginal discharge. In clinical trials, this occurred in about 14% of users and is typically caused by the melting of the fat-based insert rather than an infection. Other less common side effects include abnormal Pap smear results, such as low-grade changes in cervical cells, and application site irritation. Because prasterone can be converted into androgens, some women might notice mild oily skin or acne, though this is rare at the recommended 6.5 mg dose. Always report any new or worsening symptoms to your healthcare provider to ensure they are monitored correctly.
There are no known direct interactions between alcohol consumption and the use of prasterone vaginal inserts. Because the medication is applied locally and very little of it reaches the systemic bloodstream, alcohol does not interfere with how the drug works in the vaginal tissue. However, it is always wise to consume alcohol in moderation, as excessive drinking can impact overall health and may complicate other menopausal symptoms. If you have concerns about alcohol and your specific health conditions, you should discuss them with your doctor. Maintaining a healthy lifestyle supports the overall effectiveness of hormonal therapies.
No, prasterone is not safe for use during pregnancy and is not indicated for women who are pregnant or may become pregnant. The medication is specifically designed for postmenopausal women who no longer have the potential for pregnancy. Exposure to the hormonal metabolites of prasterone, particularly androgens, could potentially harm a developing fetus or interfere with the normal hormonal balance required for a healthy pregnancy. If you suspect you are pregnant, you should stop using the medication immediately and contact your healthcare provider. It is also not recommended for use while breastfeeding.
Most women begin to notice an improvement in vaginal dryness and comfort within the first few weeks of consistent daily use. However, the full clinical benefits for painful intercourse typically take about 12 weeks of regular treatment to be fully realized. During this time, the vaginal tissues are gradually repairing and becoming more resilient. It is important to use the medication every night as prescribed to maintain these improvements. If you do not notice any change in your symptoms after 8 to 12 weeks, you should consult your doctor to re-evaluate your treatment plan.
Yes, you can stop taking prasterone suddenly, as it does not cause a physical withdrawal syndrome or require a tapering period. However, because prasterone treats the symptoms of vulvovaginal atrophy rather than curing the underlying cause (menopause), your symptoms like dryness and painful intercourse are likely to return once you stop. The vaginal lining will eventually return to its previous thin and fragile state without the hormonal support provided by the medication. If you wish to discontinue treatment, it is best to discuss it with your healthcare provider first to explore alternative options for managing your symptoms.
If you miss a dose of prasterone, you should use the insert as soon as you remember, unless it is nearly time for your next scheduled dose. In that case, simply skip the missed dose and continue with your regular nightly routine. You should never use two inserts at the same time to make up for a missed dose, as this could increase the risk of local irritation or unnecessary systemic exposure. Consistency is key to the effectiveness of prasterone, so try to keep the inserts in a visible place near your bed to help you remember your nightly dose.
Weight gain was not a common side effect reported in the clinical trials for prasterone vaginal inserts. While some women in studies experienced minor weight fluctuations, these were generally consistent with the natural weight changes often seen during and after menopause. Because prasterone acts primarily locally and uses a very low dose, it does not typically cause the significant systemic metabolic changes associated with some oral hormone therapies. If you experience sudden or significant weight gain while using prasterone, you should discuss this with your doctor to rule out other potential causes.
Prasterone can be taken with many common medications, but it may interact with other hormonal treatments. You should avoid using other vaginal products, such as estrogen creams or rings, at the same time as prasterone unless specifically directed by your doctor. There is also a theoretical concern that prasterone could interfere with the effectiveness of certain breast cancer treatments, such as aromatase inhibitors or tamoxifen. Always provide your healthcare provider with a complete list of all prescription drugs, over-the-counter medicines, and herbal supplements you are using to ensure there are no dangerous interactions.
As of 2026, prasterone is primarily available as the brand-name product Intrarosa. While DHEA (the active ingredient in prasterone) is widely available as an over-the-counter dietary supplement, these supplements are not the same as the FDA-approved prescription vaginal insert. Supplements are not regulated for the specific treatment of vulvovaginal atrophy and may not provide the same localized effect or safety profile. Generic versions of the prescription insert may become available in the future as patents expire, but currently, you should use the specific product prescribed by your doctor to ensure you are receiving the correct clinical dose.
Other drugs with the same active ingredient (Prasterone)