Menopause Clinical Trial
Official title:
A Placebo-controlled Study Examining the Morphological/Biochemical Effects of Intrarosa on the Vulvar Vestibule and Vagina in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
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.
Tissues in the genitourinary system are both androgen- and estrogen-dependent. The clitoris,
vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor are
androgen-responsive. In addition, the minor vestibular glands and the major vestibular glands
(Bartholin's and Skene's) are androgen-dependent, mucin-secreting glands. Deficiencies of
both estrogens and androgens can occur both naturally during menopause or iatrogenically
because of certain medications (e.g. Depo Lupron, spironolactone) or surgically
(oophorectomy). Menopause-related deficiencies of these sex hormones lead to atrophic changes
in the genitourinary system which have been termed genitourinary syndrome of menopause (GSM).
While erythema is a nonspecific finding in atrophic tissue, focal painful erythema in the
androgen-dependent vestibule, particularly near the ostia of the Bartholin's glands (4:00 and
8:00 o'clock) and Skene's glands (1:00 and 11:00 o'clock) or lesser vestibular glands, is
highly suggestive of GSM. Patients with GSM will frequently complain of penetrative
dyspareunia and experience allodynia with the cotton swab palpation of the vulvar vestibule.
During examination of the vulvar vestibule, the examiner might note general pallor with
superimposed erythema. Physical exam can be improved by magnification (i.e. vulvoscopy).
Historically, GSM treatment involved both androgens and estrogens. However, in the absence of
information about intracrinology, over the past few decades, estradiol-based therapies have
been used exclusively. More recently, double-blind, placebo controlled clinical trials
demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in
postmenopausal women including moderate to severe dyspareunia. These trials have demonstrated
improvement in both subjective measures (such as improvement in dyspareunia) as well as
objective measurement of vaginal health (improved vaginal maturation index, decreased vaginal
pH) but they have not attempted to demonstrate improvement in the health of the vulvar
tissue.
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