Intrarosa Drug Information
Generic name: PRASTERONE
Uses of Intrarosa
® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Dosage & Administration of Intrarosa
Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime.
Side Effects of Intrarosa
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In four placebo-controlled, 12-week clinical trials, vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group. There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group.
In a 52-week non-comparative clinical trial, vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving INTRAROSA with an incidence of ≥ 2 percent. There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. The eleven cases of abnormal Pap smear at 52 weeks include one case of low-grade squamous intraepithelial lesion (LSIL), and ten cases of atypical cells of undetermined significance (ASCUS).
Warnings & Cautions for Intrarosa
Current or Past History of Breast Cancer 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.
Contraindications for Intrarosa
Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding.
Clinical Studies of Intrarosa
The effectiveness of INTRAROSA on moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause was examined in two primary 12-week placebo-controlled efficacy trials. The first clinical trial (Trial 1) was a 12-week randomized, double-blind and placebo-controlled trial that enrolled 255 generally healthy postmenopausal women between 40 to 75 years of age (mean 58.6 years) who, at baseline, identified moderate to severe dyspareunia as their most bothersome symptom of vulvar and vaginal atrophy. In addition to moderate to severe dyspareunia, women had ≤ 5% superficial cells on vaginal smear and a vaginal pH > 5. Women were randomized in a 1:1:1 ratio between three treatment groups who received daily INTRAROSA (n=87), one active comparator vaginal insert (n=87), or placebo (n=81). All women 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. The second clinical trial (Trial 2) was a 12-week randomized, double-blind and placebo-controlled trial that enrolled 558 generally healthy postmenopausal women between 40 to 80 years of age (mean 59.5 years) who, at baseline, had identified moderate to severe dyspareunia as their most bothersome symptom of vulvar and vaginal atrophy.
In addition to dyspareunia, women had ≤ 5% superficial cells on vaginal smear and a vaginal pH > 5. Women were randomized in a 2:1 ratio to receive once daily vaginal insert containing 6.5 mg INTRAROSA (n=376) or placebo (n=182). The primary endpoints and study conduct were the same or similar to those in Trial 1. The primary efficacy results obtained in the Intent-to-Treat (ITT) population in Trial 1 are shown in Table 2. Table 2: Efficacy Summary in Primary 12-Week Trial 1: ITT Population (LOCF) 1 Difference from placebo =INTRAROSA (Week 12 mean – Baseline mean) – Placebo (Week 12 mean – Baseline mean). 2 ANCOVA: Treatment as the main factor and Baseline value as the covariate. Placebo N = 77 INTRAROSA N = 81 Dyspareunia Baseline Mean Severity Week 12 Mean Severity Mean Change in Severity (SD) Difference from Placebo 1 p-value 2 2.58 1.71 -0.87 - - 2.63 1.36 -1.27 -0.40 0.0132 % Superficial Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 0.73 1.64 0.91 - - 0.68 6.30 5.62 4.71 <0.0001 % Parabasal Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 68.48 66.86 -1.62 - - 65.05 17.65 -47.40 -45.77 <0.0001 Vaginal pH Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 6.51 6.31 -0.21 - - 6.47 5.43 -1.04 -0.83 <0.0001 The primary efficacy results obtained in the Intent-to-Treat (ITT) population in Trial 2 are shown in Table 3. Table 3: Efficacy Summary in Primary 12-Week Trial 2: ITT Population (LOCF) 1 Difference from placebo =INTRAROSA (Week 12 mean – Baseline mean) – Placebo (Week 12 mean – Baseline mean). 2 ANCOVA: Treatment as the main factor and Baseline value as the covariate. Placebo N = 157 INTRAROSA N = 325 Dyspareunia Baseline Mean Severity Week 12 Mean Severity Mean Change in Severity (SD) Difference from Placebo 1 p-value 2 2.56 1.50 -1.06 - - 2.54 1.13 -1.42 -0.35 0.0002 % Superficial Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 1.04 2.78 1.75 - - 1.02 11.22 10.20 8.46 <0.0001 % Parabasal Cells Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 51.66 39.68 -11.98 - - 54.25 12.74 -41.51 -29.53 <0.0001 Vaginal pH Baseline Mean Week 12 Mean Mean Change (SD) Difference from Placebo 1 p-value 2 6.32 6.05 -0.27 - - 6.34 5.39 -0.94 -0.67 <0.0001
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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