clinically Proven Results

INTRAROSA is clinically proven to treat moderate to severe painful sex due to menopause.

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Primary Efficacy Results

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Statistically significant
decrease in pain during sex

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Statistically significant
improvement in vaginal tissue*

These results are from two 12-week, randomized, double-blind, placebo-controlled studies that included 640 postmenopausal women with moderate to severe painful sex as their most bothersome symptom.

*Decreased percentage of parabasal cells, reduced vaginal pH, and increased percentage of superficial cells

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Sustained decrease in pain during sex over
1 year of continued daily use at bedtime

These results are from a 52-week non-comparative, open-label clinical trial that included 183 postmenopausal women with moderate to severe painful sex as their most bothersome symptom.

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Using INTRAROSA has worked to relieve my moderate to severe pain during sex. I had no idea that my vaginal tissue could be part of my problem.
– Linda W.

In clinical trials, INTRAROSA was shown to reduce moderate to severe pain during sex when used daily at bedtime for 12 weeks.
Individual results may vary.

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Demonstrated Safety in INTRAROSA Clinical Trials

The most frequently reported side effects of INTRAROSA are vaginal discharge and changes on Pap smear


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In a 52-week non-comparative clinical trial, the most frequently reported side effects were vaginal discharge (14% of women) and changes in Pap smear (2.1%).

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INTRAROSA is the only prescription treatment for moderate to severe painful sex due to menopause with no boxed safety warning

Additional exploratory findings

In one clinical study, women completed a validated survey to understand their sexual function. These are initial findings that have not been intensely studied.

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INTRAROSA showed improvement in sexual function across all areas, including1:

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Desire

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Arousal

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Lubrication

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Satisfaction

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Pain with sexual activity

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Orgasm

Get information on how to use intrarosa once daily at bedtime

Using INTRAROSA
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Indication

INTRAROSA vaginal inserts are a prescription medicine used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.

Important Risk Information

Do not use INTRAROSA vaginal inserts if you have vaginal bleeding that has not been checked by your healthcare provider.

Before using INTRAROSA vaginal inserts, tell your healthcare provider about all of your medical conditions, including if you:

  • Have, have had, or think you may have had breast cancer. Prasterone, an ingredient in INTRAROSA vaginal inserts, is changed in your body to estrogen. Estrogen medicines are not for use in women who have, have had, or think they may have had breast cancer.

The most common side effects of INTRAROSA vaginal inserts are vaginal discharge and changes on Pap smear.

These are not all of the possible side effects of INTRAROSA vaginal inserts.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

Please see Patient Information in full Prescribing Information.

Reference: 1. Labrie F, Derogatis L, Archer DF, et al. Effect of intravaginal prasterone on sexual dysfunction in postmenopausal women with vulvovaginal atrophy. J Sex Med. 2015;12:2401-2412.