Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
Status:
Unknown status
Trial end date:
2021-01-02
Target enrollment:
Participant gender:
Summary
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The
clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor
all depend on androgens for normal function. In addition, the glands, which secrete
lubrication during sexual arousal, also require androgens to function. Deficiencies of both
estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of
these hormones lead to thinning in the tissues of the genital and urinary systems which have
been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently
complain of dryness and/or pain during sexual intercourse.
Historically, GSM treatment involved both androgens and estrogens, However, over the past few
decades estrogen based therapies have become much more common. More recently, clinical trials
have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in
menopausal women who have moderate to severe pain with intercourse.
Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug
Administration (FDA) 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.