Clinical Study ResultsINTRAROSA: Clinical study results and side effects

Clinical Study ResultsINTRAROSA: Clinical study results and side effects

Primary efficacy results

In 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, INTRAROSA showed:

  • Statistically significant decrease in pain during sex
  • Statistically significant improvement in vaginal tissue*
*Increased percentage of superficial cells, decreased percentage of parabasal cells, and reduced vaginal pH.

In a 52-week non-comparative ? clinical trial that included 183 postmenopausal women with moderate to severe painful sex as their most bothersome symptom, INTRAROSA showed:

  • Sustained decrease in pain during sex for over 1 year with continued use

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.

INTRAROSA showed improvement in sexual function across all areas, including1:
  • Desire
  • Arousal
  • Lubrication
  • Orgasm
  • Satisfaction
  • Pain with sexual activity

Safety

In four placebo-controlled, 12-week clinical trials, the most frequently reported side effect was vaginal discharge (5.7% of women).

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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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 fda.gov/medwatch or call 1-800-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(12): 2401-2412.

Reference: 1. Typical postmenopausal ranges for androgens, estrogens, and DHEA have been noted in various studies, but were not part of the INTRAROSA studies.

Reference: 1. Typical postmenopausal ranges for androgens, estrogens, and DHEA have been noted in various studies, but were not part of the INTRAROSA studies.

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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 fda.gov/medwatch or call 1-800-FDA-1088.

Please see Patient Information in full Prescribing Information.