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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INTRAROSA patient support program: Blossom

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