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Intrarosa
Published
Product name
Intrarosa
Active ingredient
Prasterone
Submission type
New Chemical Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Intrarosa (prasterone) was approved for the following therapeutic use:
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
How this medicine works
Prasterone is biochemically and biologically identical to endogenous human dehydroepiandrosterone (DHEA), a precursor steroid with no or little pharmacological activity itself that is converted into oestrogens and androgens. These metabolites are formed from prasterone activate oestrogen and androgen receptors. Intrarosa is thus different from the oestrogens preparations since it also delivers androgen metabolites.
An increase in the number of superficial and intermediate cells and decrease in the number of parabasal cells in the vaginal mucosa is noted. In addition, the vaginal pH decreased towards the normal range, thus facilitating the growth of the normal bacterial flora.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Intrarosa was considered favourable for the therapeutic use approved.
Sponsor