Prasterone

Status

FDA-approved. FDA-approved labeling exists as Intrarosa for moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Labeling notes it is not recommended in women with undiagnosed abnormal genital bleeding or a history of breast cancer.

What it is

A local DHEA preparation approved for painful intercourse after menopause.

What published research measured

Prasterone, DHEA formulated as a vaginal insert, and a good example of a delivery route changing what a molecule is. Administered locally, it is converted within vaginal cells to oestrogens and androgens by intracellular enzymes, with the stated aim of acting on local tissue while serum sex steroid concentrations remain within the postmenopausal range. Randomized placebo-controlled trials support improvement in moderate to severe dyspareunia and in objective measures of vaginal atrophy. It holds a full approval on that evidence, unlike oral DHEA, whose systemic trials have largely been negative — a distinction worth keeping clear, since the same molecule is involved.

Source

Randomized placebo-controlled trials of prasterone in dyspareunia · FDA labeling for Intrarosa

Sources

No linked primary source is on file for this entry yet.

Educational use only, never medical advice. No doses.