Short answer: Both are vaginal inserts for menopause changes. Intrarosa holds 6.5 mg prasterone (DHEA), used every night, for pain during sex; it has no boxed warning.1 Vagifem holds 10 mcg estradiol, used daily for 2 weeks then twice a week, for atrophic vaginitis; it carries the estrogen boxed warning.2 Neither label compares the two.
| Intrarosa | Vagifem | |
|---|---|---|
| What it is | Prasterone (DHEA), which the body converts into androgens and estrogens1 | Estradiol, an estrogen2 |
| Approved for | Moderate to severe pain during sex (dyspareunia) from menopausal vulvar and vaginal atrophy1 | Atrophic vaginitis due to menopause2 |
| Schedule | One 6.5 mg insert every night at bedtime1 | One 10 mcg insert daily for 2 weeks, then twice a week2 |
| Trial result at 12 weeks | Pain-during-sex score fell 1.27 vs 0.87 on placebo (trial 1) and 1.42 vs 1.06 (trial 2)1 | Most bothersome symptom score fell 1.20 vs 0.84 on placebo2 |
| Common side effects | Vaginal discharge 5.71% vs 3.66% on placebo; abnormal Pap smear 2.1% at 52 weeks, no placebo group1 | Vaginal yeast infection 8% vs 3%; itching 8% vs 2%; back pain 7% vs 2%2 |
| Missed dose | No rule in the label1 | No rule in the label2 |
| Boxed warning | None1 | WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER2 |
Intrarosa's only listed warning is about breast cancer: estrogen is a breakdown product of prasterone, estrogen is not to be used with a history of breast cancer, and Intrarosa has not been studied in women with that history. It should not be used with undiagnosed abnormal genital bleeding.1 Vagifem's label says some estradiol is absorbed into the body, so the warnings for estrogen taken by mouth apply, including its boxed warning on endometrial cancer, stroke and clots, probable dementia and breast cancer.2
In Vagifem's 12-month trial, biopsies found one endometrial cancer and one hyperplasia among 172 women.2 After 12 weeks of Intrarosa, trough blood levels of prasterone, testosterone and estradiol rose 47%, 21% and 19% from baseline.1 These numbers come from separate trials with different people, lengths and methods, so they are not a head-to-head comparison.
Which, if either, fits is for your prescriber. More detail: Intrarosa side effects, Vagifem side effects, the Intrarosa and Vagifem dosing schedules, the DHEA and vaginal estradiol guides, and Osphena vs Intrarosa: how do the pill and the vaginal insert differ?.