Intrarosa (Prasterone): Uses, Dosage & Side Effects
Vaginal pessary for the treatment of vulvovaginal atrophy in postmenopausal women
Quick Facts About Intrarosa
Key Takeaways
- Intrarosa is a vaginal pessary containing 6.5 mg prasterone (DHEA) used to treat vulvovaginal atrophy symptoms in postmenopausal women, including vaginal dryness and painful intercourse.
- The active substance is converted locally into estrogens and androgens within vaginal tissue without causing significant systemic hormonal changes – serum levels remain within the normal postmenopausal range.
- Unlike oral hormone replacement therapy, Intrarosa does not require the addition of a progestogen, as it does not stimulate endometrial growth.
- The standard dose is one pessary inserted vaginally at bedtime daily, with regular medical check-ups recommended at least twice per year.
- The most common side effect is vaginal discharge; Intrarosa is contraindicated in women with known or suspected breast cancer, estrogen-dependent cancers, undiagnosed vaginal bleeding, or history of venous thromboembolism.
What Is Intrarosa and What Is It Used For?
Quick Answer: Intrarosa is a prescription vaginal pessary containing 6.5 mg of prasterone (dehydroepiandrosterone, or DHEA). It is used to treat moderate to severe symptoms of vulvovaginal atrophy (VVA) – also known as genitourinary syndrome of menopause (GSM) – in postmenopausal women. These symptoms include vaginal dryness, irritation, itching, and painful sexual intercourse (dyspareunia).
Vulvovaginal atrophy is an extremely common condition that affects up to 50–60% of postmenopausal women, though many do not seek medical treatment. After menopause, the ovaries stop producing significant amounts of estrogen, leading to thinning, drying, and inflammation of the vaginal walls. This hormonal decline also results in reduced vaginal elasticity, increased vaginal pH, and changes in the vaginal microbiome, all of which contribute to discomfort and an increased susceptibility to urinary tract infections.
The active substance in Intrarosa, prasterone, is chemically identical to the naturally occurring hormone dehydroepiandrosterone (DHEA) produced by the adrenal glands. DHEA serves as a precursor hormone – meaning it is inactive on its own but is converted by enzymes within target cells into active sex steroids. When administered intravaginally, prasterone is taken up by vaginal epithelial cells and locally converted into estradiol, estrone, testosterone, and dihydrotestosterone (DHT) through a process known as intracrinology.
This intracrine mechanism is what makes Intrarosa unique compared to traditional vaginal estrogen products. Rather than delivering a preformed active hormone, it supplies the precursor and allows the vaginal tissue to produce exactly the hormones it needs, in the amounts it needs. The hormones are synthesized, exert their effect, and are subsequently inactivated – all within the same cells. This results in minimal systemic absorption, with serum levels of estradiol, testosterone, and DHEA remaining within the normal ranges observed in postmenopausal women not using hormone therapy.
Intrarosa was approved by the European Medicines Agency (EMA) in 2018 and by the U.S. Food and Drug Administration (FDA) in 2016 (marketed as Intrarosa in the EU and as prasterone vaginal insert in the US). It is manufactured by Endoceutics S.A., based in Belgium, with pharmaceutical production by Basic Pharma Manufacturing B.V. in the Netherlands.
What Should You Know Before Using Intrarosa?
Quick Answer: Before starting Intrarosa, tell your doctor about your complete medical history, including any history of breast cancer, blood clots, liver disease, or endometrial hyperplasia. Intrarosa is contraindicated in women with known or suspected estrogen-dependent cancers, undiagnosed vaginal bleeding, active venous thromboembolism, or severe liver disease.
Although Intrarosa acts locally in vaginal tissue with minimal systemic absorption, it is still classified within the broader category of hormone-related treatments. Therefore, many of the precautions that apply to systemic hormone replacement therapy (HRT) are included in the prescribing information as a precautionary measure. Your doctor will assess your individual risk factors before prescribing Intrarosa.
Contraindications
Do not use Intrarosa if any of the following applies to you:
- Known or suspected breast cancer, or a history of breast cancer
- Known or suspected estrogen-dependent malignancy, such as endometrial cancer
- Undiagnosed abnormal vaginal bleeding
- Untreated endometrial hyperplasia (abnormal thickening of the uterine lining)
- Current or previous venous thromboembolism (deep vein thrombosis or pulmonary embolism)
- Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency)
- Current or recent arterial thromboembolic disease (e.g., heart attack, stroke, or angina)
- Active or previous liver disease with abnormal liver function tests
- Known porphyria (a rare inherited blood disorder)
- Allergy to prasterone or any excipient in the product (hard fat/adeps solidus)
If any of these conditions develops for the first time while using Intrarosa, stop the medication immediately and contact your doctor.
Warnings and Precautions
Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen:
- Uterine fibroids (leiomyomas)
- Endometriosis or endometrial hyperplasia
- Increased risk of blood clots (e.g., due to obesity, prolonged immobilization, family history, lupus, or cancer)
- Increased risk of estrogen-dependent cancers (e.g., first-degree relative with breast cancer)
- High blood pressure
- Liver disorders, including benign liver tumors
- Diabetes mellitus
- Gallstones
- Migraine or severe headaches
- Systemic lupus erythematosus (SLE)
- Epilepsy
- Asthma
- Otosclerosis (hearing disorder)
- Elevated triglycerides
- Fluid retention due to cardiac or renal problems
- Yellowing of the skin or eyes (jaundice) – may indicate liver disease
- Sudden severe increase in blood pressure with headache, fatigue, or dizziness
- New onset of migraine-type headache
- Signs of a blood clot: painful swelling and redness of the legs, sudden chest pain, or difficulty breathing
- If you become pregnant
Intrarosa is not a contraceptive. If fewer than 12 months have passed since your last menstrual period, or if you are under 50 years of age, you may still need to use contraception to prevent pregnancy. Discuss this with your doctor.
HRT-Related Cancer Risks and Intrarosa
The prescribing information for Intrarosa includes information about cancer risks associated with systemic hormone replacement therapy. It is important to understand that these risks primarily apply to HRT products that circulate in the bloodstream at higher concentrations. Intrarosa is used locally in the vagina, and systemic absorption is very low. The following information is provided for completeness:
Endometrial cancer: Long-term use of estrogen-only systemic HRT can increase the risk of endometrial hyperplasia and cancer. However, clinical trials with Intrarosa over 52 weeks demonstrated that the endometrial lining remained thin (atrophied) in all treated women. The systemic absorption is so low that the addition of a progestogen is not required.
Breast cancer: Systemic combination HRT (estrogen plus progestogen) and possibly estrogen-only HRT are associated with a slightly increased risk of breast cancer after prolonged use. This additional risk decreases to baseline within a few years of stopping treatment. The relationship between intravaginal prasterone and breast cancer risk has not been established in long-term studies. Rare cases of breast cancer were reported in the 52-week clinical trial program.
Ovarian cancer: Use of systemic estrogen-only HRT has been associated with a slightly elevated risk of ovarian cancer. This risk is very small in absolute terms. The relevance to Intrarosa, given its minimal systemic absorption, is uncertain.
Cardiovascular Considerations
Venous thromboembolism (VTE): Systemic HRT increases the risk of VTE by approximately 1.3 to 3 times, particularly during the first year of use. In clinical trials of Intrarosa, no cases of deep vein thrombosis were observed. One case of pulmonary embolism occurred, representing a lower incidence than in the placebo group. If you are scheduled for surgery, inform your surgeon that you are using Intrarosa, as you may need to discontinue use 4–6 weeks before the procedure to reduce the risk of blood clots.
Stroke: Systemic HRT is associated with approximately 1.5-fold increased risk of stroke. No cases of stroke were observed in Intrarosa clinical trials.
Heart disease: Women using estrogen-only systemic HRT have no increased risk of coronary heart disease. Intrarosa has not been studied specifically in women with a history of cardiovascular disease.
Pregnancy and Breastfeeding
Intrarosa is intended exclusively for postmenopausal women and should not be used during pregnancy or breastfeeding. If you become pregnant while using Intrarosa, stop the medication immediately and contact your doctor. Intrarosa is not intended for fertile women, and its effects on fertility have not been studied.
Effects on Driving and Machine Operation
Intrarosa has no known effect on the ability to drive or operate machinery.
How Does Intrarosa Interact with Other Drugs?
Quick Answer: No formal drug interaction studies have been conducted with Intrarosa. However, it should not be used in combination with systemic hormone replacement therapy (estrogen-only or combined estrogen-progestogen) or with vaginal estrogen products, as there are no safety data for concurrent use.
Prasterone is an endogenous steroid hormone precursor that is metabolized locally within vaginal tissue through intracrine enzymatic pathways. Because the systemic absorption is very low, significant pharmacokinetic drug interactions are considered unlikely. However, the following considerations apply:
| Medication | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Systemic HRT (estrogen ± progestogen) | Additive hormonal effects | Not studied; potential for increased systemic hormone levels | Do not use concurrently |
| Vaginal estrogen products | Additive local hormonal effects | Not studied; no safety data for combination use | Do not use concurrently |
| Androgen supplements (testosterone, DHEA) | Additive androgenic effects | Not studied; theoretical risk of androgenic side effects | Discuss with your doctor |
| Latex condoms, diaphragms, cervical caps | Physical/mechanical | The hard fat base of the pessary may weaken latex products | Use alternative barrier methods or non-latex products |
| Vaginal anti-infective agents | Sequential use | Active vaginal infection should be treated first | Treat infection before starting Intrarosa |
Always inform your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take. This includes prescription medications, over-the-counter drugs, herbal supplements, and topical vaginal products.
The hard fat (adeps solidus) base in Intrarosa pessaries may weaken latex-based barrier contraceptives such as condoms, diaphragms, and cervical caps. If you use these methods for contraception or STI prevention, speak with your healthcare provider about alternative options or timing of use.
What Is the Correct Dosage of Intrarosa?
Quick Answer: The recommended dose of Intrarosa is one vaginal pessary (6.5 mg prasterone) inserted into the vagina once daily at bedtime. There is only one available strength. Treatment should be continued as long as symptoms require, with medical review at least twice per year.
Always use Intrarosa exactly as prescribed by your doctor or pharmacist. Your doctor will aim to prescribe the lowest effective dose for the shortest necessary duration. If you feel the dose is too strong or not effective enough, discuss this with your prescriber.
Adults (Postmenopausal Women)
Standard Dosage
Dose: One vaginal pessary (6.5 mg) per day
Route: Intravaginal insertion
Timing: At bedtime
Duration: As directed by your doctor, with review at least every 6 months
How to Insert the Pessary
The pessary can be inserted using your finger or with the reusable applicator included in the package. Each box contains 28 pessaries and 6 applicators. Follow these steps:
- Wash your hands thoroughly before handling the pessary.
- Remove one pessary from the blister pack.
- If using the applicator, place the pessary into the open end of the applicator.
- Lie on your back with your knees bent, or stand with one foot raised on a stool – whichever is most comfortable.
- Gently insert the pessary (with finger or applicator) into the vagina as far as comfortably possible.
- If using the applicator, press the plunger to release the pessary, then withdraw the applicator.
- Clean the applicator after each use with mild soap and warm water. Each applicator can be reused for up to one week before replacing with a new one.
Children and Adolescents
Intrarosa is intended for use only in adult postmenopausal women. It has no approved use in children or adolescents and should not be used in these populations.
Elderly Patients
No dose adjustment is required for elderly patients. Intrarosa is specifically designed for postmenopausal women and has been studied in women aged up to 80 years. Clinical efficacy and safety are similar across age groups within the postmenopausal population.
Missed Dose
If you forget to insert a pessary, do so as soon as you remember. However, if it is less than 8 hours until your next scheduled dose, skip the missed dose entirely. Do not use two pessaries at once to make up for a forgotten dose.
Overdose
In the event that more pessaries than prescribed are used, a vaginal rinse (douche) may be considered. Symptoms of overdose are unlikely given the local nature of the treatment and the low systemic absorption. If you are concerned about an overdose, contact your doctor or pharmacist for guidance.
Before Surgery
If you are scheduled for surgery, inform your surgeon that you are using Intrarosa. You may need to stop treatment 4–6 weeks before the operation to reduce the theoretical risk of blood clots. Ask your doctor when you can safely resume Intrarosa after surgery.
What Are the Side Effects of Intrarosa?
Quick Answer: The most commonly reported side effect of Intrarosa is vaginal discharge, which is caused by the melting of the hard fat base combined with increased vaginal secretions from the treatment. Other common side effects include abnormal Pap smear results and weight changes. Serious side effects are rare with Intrarosa due to its low systemic absorption.
Like all medicines, Intrarosa can cause side effects, although not everyone experiences them. The following side effects were reported in clinical trials involving over 1,000 postmenopausal women treated with Intrarosa for up to 52 weeks:
Very Common
May affect more than 1 in 10 users
- Vaginal discharge (due to melting of the pessary base and increased vaginal secretions)
Common
May affect up to 1 in 10 users
- Abnormal Pap smear result (usually ASCUS or LGSIL – low-grade changes that typically resolve spontaneously)
- Weight change (increase or decrease)
Uncommon
May affect up to 1 in 100 users
- Benign cervical or uterine polyps
- Benign breast masses (lumps)
Reported with Estrogen HRT (Not Observed with Intrarosa in Trials)
These effects are associated with systemic estrogen use and included for completeness
- Gallbladder disease
- Skin discoloration (chloasma), especially on the face and neck
- Erythema nodosum (tender, red skin nodules)
- Erythema multiforme (skin rash with target-like redness or sores)
- Venous thromboembolism (blood clots in legs or lungs)
- Stroke
- Probable memory impairment when HRT is started after age 65
The vaginal discharge experienced by many users is generally not a cause for concern and does not require discontinuation of treatment. It results from the hard fat base of the pessary melting at body temperature, combined with the normal physiological increase in vaginal secretions that occurs as the vaginal tissue becomes healthier with treatment.
If you experience any unusual vaginal bleeding or spotting, contact your doctor. While this is usually harmless, it may occasionally indicate endometrial thickening that requires evaluation.
If you experience any side effects while using Intrarosa, including any not listed here, please report them to your healthcare provider. You can also report suspected adverse reactions directly to your national pharmacovigilance authority (e.g., the FDA MedWatch program in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA EudraVigilance system in Europe). Reporting helps to continuously monitor the benefit-risk balance of medicines.
How Should You Store Intrarosa?
Quick Answer: Store Intrarosa at or below 30°C (86°F). Do not freeze. Keep the pessaries in their original blister packaging until use and store out of the reach and sight of children.
- Temperature: Store at or below 30°C (86°F). Do not expose to excessive heat.
- Freezing: Do not freeze Intrarosa pessaries.
- Packaging: Keep in the original blister pack to protect from moisture and light.
- Children: Store out of the reach and sight of children.
- Expiry date: Do not use Intrarosa after the expiry date printed on the carton and blister pack after “EXP.” The expiry date refers to the last day of that month.
- Disposal: Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to properly dispose of medicines that are no longer needed. This helps protect the environment.
What Does Intrarosa Contain?
Quick Answer: Each Intrarosa vaginal pessary contains 6.5 mg of prasterone (DHEA) as the active ingredient, with hard fat (adeps solidus) as the only excipient. The pessary is white to off-white and cone-shaped, approximately 28 mm in length and 9 mm in diameter at the widest point.
| Component | Role | Amount per Pessary |
|---|---|---|
| Prasterone (DHEA) | Active ingredient | 6.5 mg |
| Hard fat (adeps solidus) | Excipient (pessary base) | q.s. |
Appearance: Intrarosa pessaries are white to off-white, torpedo-shaped (conical) suppositories. They measure approximately 28 mm in length and 9 mm in diameter at the widest point.
Packaging: Intrarosa is available in packs of 28 pessaries (in blister strips) with 6 reusable applicators. The applicators are made of low-density polyethylene (LDPE) with 1% titanium dioxide colorant.
Intrarosa contains no preservatives, fragrances, dyes, or common allergens beyond the listed ingredients. The formulation is deliberately simple, with only hard fat as the excipient, which melts at body temperature to release the active substance within the vaginal cavity.
Frequently Asked Questions About Intrarosa
Medical References
- European Medicines Agency (EMA). “Intrarosa (prasterone) – Summary of Product Characteristics.” Last updated 2023. EMA Product Page Official European regulatory document for Intrarosa.
- U.S. Food and Drug Administration (FDA). “Intrarosa (prasterone) – Prescribing Information.” 2024. FDA-approved prescribing information for Intrarosa in the United States.
- Labrie F, et al. “Intravaginal prasterone (DHEA) provides local action without clinically significant changes in serum concentrations of estrogens or androgens.” Journal of Steroid Biochemistry and Molecular Biology. 2013;138:359-367. doi:10.1016/j.jsbmb.2013.08.002 Key pharmacokinetic study demonstrating minimal systemic absorption.
- Labrie F, et al. “Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.” Menopause. 2018;25(11):1339-1353. doi:10.1097/GME.0000000000001238 Pivotal clinical trial data for Intrarosa efficacy.
- The North American Menopause Society (NAMS). “Management of Genitourinary Syndrome of Menopause in Women With or at High Risk for Breast Cancer: Consensus Recommendations.” Menopause. 2018;25(6):596-608. doi:10.1097/GME.0000000000001121 NAMS consensus on managing vulvovaginal symptoms in menopause.
- International Menopause Society (IMS). “Recommendations on Women’s Midlife Health and Menopause Hormone Therapy.” Climacteric. 2024;27(1):7-30. Updated international guidelines on menopause management.
- Archer DF, et al. “Treatment of vulvovaginal atrophy with intravaginal DHEA: the pivotal phase III clinical program.” Maturitas. 2015;82(3):322. Overview of the phase III clinical trial program supporting Intrarosa approval.
- World Health Organization (WHO). “WHO Model List of Essential Medicines, 23rd List.” 2023. WHO Essential Medicines WHO reference for essential medicines classification.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Information is based on EMA-approved Summary of Product Characteristics, FDA prescribing information, peer-reviewed clinical trial data, and international menopause society guidelines.
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