Intrarosa (prasterone vaginal insert)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved November 2016

Specific Treatments:

moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

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General Information

Intrarosa (prasterone) is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of Intrarosa in postmenopausal women with vulvar and vaginal atrophy is not fully established.

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

Intrarosa is supplied as a vaginal insert. Administer one Intrarosa vaginal insert once daily at bedtime, using the provided applicator.

Clinical Results

FDA Approval

The FDA approval of Intrarosa for moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause was based on two primary 12-week placebo-controlled efficacy trials. The trials enrolled 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. The women were randomly assigned to receive Intrarosa or a placebo vaginal insert. All subjects were assessed for improvement from Baseline to Week 12 for four co-primary efficacy endpoints: most bothersome moderate to severe symptom of dyspareunia, the percentage of vaginal superficial cells, the percentage of parabasal cells, and vaginal pH. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse. 

Side Effects

Adverse effects associated with the use of Intrarosa may include, but are not limited to, the following:

  • vaginal discharge
  • abnormal Pap smear

 

Mechanism of Action

Intrarosa (prasterone) is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of Intrarosa in postmenopausal women with vulvar and vaginal atrophy is not fully established.

Additional Information

For additional information regarding Intrarosa or moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause, please visit http://www.endoceutics.com/