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Prasterone (Intrarosa) is an intravaginal product used to treat moderate to severe dyspareunia due to vulvar and vaginal atrophy caused by menopause.1 The mechanism of action of intravaginal prasterone is not known, but it may involve local metabolism to estrogens and androgens.2,3
| Drug | Dosage | Dose form | Cost* |
|---|---|---|---|
| Prasterone vaginal insert (Intrarosa) | One 6.5-mg vaginal insert, using provided applicator once daily at bedtime | 6.5-mg vaginal insert | $210 |
*-Estimated retail price of one month of treatment based on information obtained at https://www.goodrx.com (accessed October 24, 2018).
Safety
In a 52-week noncomparative clinical trial of 530 postmenopausal women with previously normal Papanicolaou (Pap) test results, 2.1% who used intravaginal prasterone developed abnormal Pap tests at study completion. Most of these abnormalities consisted of atypical squamous cells of undetermined significance (ASCUS).1,3 These results are similar to the incidence of ASCUS in postmenopausal patients outside of this trial, but follow-up data on Pap tests in this population have not been reported. Prasterone has not been shown to increase serum steroid concentrations, nor has it been linked to the development of endometrial hyperplasia or endometrial cancer.4,5 Prasterone has not been studied in patients with a history of breast cancer, renal impairment, or hepatic impairment.1,3 It is contraindicated in women with undiagnosed abnormal genital bleeding.1 Prasterone should be prescribed only for use in postmenopausal...