Sustained moderate to severe dyspareunia relief for up to 1 year with continued treatment1

Sustained improvement—even in women who reported moderate to severe dyspareunia as their most bothersome symptom of vulvovaginal atrophy (n=183)
Actor portrayal

Severity score decrease in women who reported moderate to severe dyspareunia as their most bothersome symptom of VVA (n=183)*

Severity score decrease

Study Design

In a 52-week, open-label, phase 3 clinical trial (N=521, safety population, n=454), healthy, nonhysterectomized postmenopausal women (who rated at least one of the following symptoms of VVA as mild to severe: dyspareunia, vaginal dryness, or vaginal or vulvar irritation/itching) were evaluated. Women with moderate to severe dyspareunia as their most bothersome symptom (n=183) were assessed for improvement from baseline to Week 52.
VVA=vulvovaginal atrophy.
53.3% decrease in pain score at Week 12 and 66.1% decraese in pain at Weeek 52
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Indication

INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Important Safety Information

INTRAROSA is contraindicated in women with undiagnosed abnormal genital bleeding.

Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.

In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal discharge and abnormal Pap smear.

To report SUSPECTED ADVERSE REACTIONS, contact AMAG Pharmaceuticals at 1­-877-411-2510 or FDA at 1-800­-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

Reference: 1. Labrie F, Archer DF, Bouchard C, et al. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015;81(1):46-56.