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Vaginal DHEA Pregnancy: Not indicated in pre-menopausal women of child-bearing age, including pregnancy — if pregnancy occurs during treatment the treatment should be withdrawn immediately. There are no data on use in pregnant women and no animal reproductive toxicity studies were performed; the potential risk in humans is unknown. Not indicated during breast-feeding. Not indicated in fertile women.

Prasterone

Brand names: Intrarosa

Prasterone is intravaginal dehydroepiandrosterone (DHEA) used to treat vulvovaginal atrophy with moderate to severe symptoms in postmenopausal women.

Adult dose

Dose: Vulvar and vaginal atrophy due to menopause, in postmenopausal women: 6.5 mg prasterone (one pessary) once daily
Route: Vaginal use. The pessary can be inserted in the vagina with the finger or with an applicator provided within the identified pack, as far as it can comfortably go without force. If an applicator is used it should be activated by pulling back the plunger, the flat end of the pessary placed into the open end, the applicator inserted and the plunger pressed to release the pessary; the applicator is then withdrawn, disassembled, rinsed for 30 seconds under running water, wiped with paper towel, reassembled and kept in a clean place until next use, and each applicator discarded after one week of usage
Frequency: Once daily, at bedtime
Max: 6.5 mg — one pessary once daily, the SPC's only stated dose, reinforced by its missed-dose rule: 'If a dose is forgotten, it should be taken as soon as the patient remembers. However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary. Two pessaries should not be used to make up for a forgotten dose.' No higher figure appears anywhere in the quoted posology
Verbatim posology: 'The recommended dose is 6.5 mg prasterone (one pessary) administered once daily, at bedtime.' TREATMENT REVIEW: 'For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk.' ELDERLY: 'No dose adjustment is considered necessary in elderly women.' The indication wording above is taken from the SPC's own paediatric paragraph, which names the indication as 'vulvar and vaginal atrophy due to menopause'.

Paediatric dose

Route: Not applicable — no relevant use in children of any age group
Frequency: Not applicable
NO PAEDIATRIC DOSE IS PUBLISHED BECAUSE THE SPC GIVES NONE. Verbatim paediatric population text: 'There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause.' dosePerKg is null — this is a fixed-strength pessary and is never dosed by weight.

Dose adjustments

Renal

Since Intrarosa acts locally in the vagina, no dose adjustment is needed for postmenopausal women having renal impairment or any other systemic anomaly or disease.

Hepatic

Since Intrarosa acts locally in the vagina, no dose adjustment is needed for postmenopausal women having hepatic impairment or any other systemic anomaly or disease. Contraindicated in acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to the excipient
  • Undiagnosed genital bleeding
  • Known, past or suspected breast cancer
  • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
  • Untreated endometrial hyperplasia
  • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
  • Previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism)
  • Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency)
  • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
  • Porphyria

Side effects

  • Common: application site discharge — vaginal discharge was the most frequently observed adverse reaction, due to melting of the hard fat used as vehicle added to the expected increase in vaginal secretions; it is not required to stop treatment if vaginal discharge occurs
  • Common: abnormal Pap smear (mostly ASCUS or LGSIL)
  • Common: weight fluctuation
  • Uncommon: cervical/uterine polyps
  • Uncommon: benign breast mass
  • Class effects of hormone replacement therapy discussed in the SPC: increased risk of breast cancer with duration of use, slightly increased risk of ovarian cancer, and a 1.3-3-fold increased relative risk of venous thromboembolism
  • NOTE: the adverse reactions section of this bundle was truncated at the source-fetch limit after the venous thromboembolism paragraph, so this list is not necessarily complete

Monitoring

  • Reassess the risks and benefits at least every 6 months, continuing only as long as the benefit outweighs the risk
  • Before initiating, take a complete personal and family medical history and perform a physical examination including pelvic and breast examination, guided by the contraindications and special warnings
  • During treatment, periodic check-ups of a frequency and nature adapted to the individual woman
  • Pap smears and blood pressure measurements in accordance with currently accepted screening practices, modified to the clinical needs of the individual
  • Advise women what changes in their breasts should be reported to their doctor or nurse
  • Close supervision where the following are present, previous, or aggravated in pregnancy or previous hormone treatment: leiomyoma (uterine fibroids) or endometriosis, risk factors for thromboembolic disorders, risk factors for oestrogen-dependent tumours (e.g. first-degree heredity for breast cancer), hypertension, liver disorders (e.g. liver adenoma), diabetes mellitus with or without vascular involvement, cholelithiasis, migraine or severe headache, systemic lupus erythematosus, a history of endometrial hyperplasia, epilepsy, asthma, otosclerosis
  • Withdraw therapy immediately for jaundice or deterioration in liver function, significant increase in blood pressure, new onset of migraine-type headache, or pregnancy
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

Locally it is converted within vaginal cells to oestrogens and androgens, restoring epithelial maturation and improving vaginal symptoms with minimal change in systemic hormone levels.

Prescribing in practice

  • It is contraindicated in undiagnosed vaginal bleeding, which must be investigated before treatment.
  • It has not been studied in women with a history of breast cancer and should be used with caution where hormone-sensitive malignancy is a concern.
  • Vaginal discharge is a common local effect and is generally benign.

Monitoring

No routine laboratory monitoring is required; review symptom response and investigate any unexpected vaginal bleeding.

Counselling the patient

  • Insert the pessary into the vagina at bedtime as directed.
  • Vaginal discharge is common and usually harmless.
  • Report any unexpected vaginal bleeding to your clinician.

Evidence & guidelines

Licensed for postmenopausal vulvovaginal atrophy on the basis of randomised placebo-controlled trials, as reflected in the SPC.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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