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Vaginal or Vulvovaginal Atrophy/Atrophic Vaginitis/Genitourinary Syndrome of Menopause (GSM)
Published in Charles Theisler, Adjuvant Medical Care, 2023
DHEA: In a prospective, randomized, double-blind, and placebo-controlled clinical trial, dehydroepiandrosterone (DHEA) was applied intravaginally for 12 weeks. All three doses (0.25%, 0.5%, and 1.0%) of DHEA (Prasterone) ovules induced highly significant beneficial changes in the pH as well as in dyspareunia and vaginal dryness at two weeks.4,5
Endocrine Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
A number of other estrogenic agents are available (e.g., tibolone, prasterone, estradiol, estriol, bazedoxifene acetate, and conjugated estrogens) but these are used for noncancer purposes relating to estrogen deficiency in women (e.g., vaginal atrophy, menopause symptoms, osteoporosis) and are not discussed any further here.
Pharmacotherapeutic options for the treatment of menopausal symptoms
Published in Expert Opinion on Pharmacotherapy, 2021
Andrea R. Genazzani, Patrizia Monteleone, Andrea Giannini, Tommaso Simoncini
Vaginal DHEA, also named prasterone, is the only androgen therapy approved by the FDA and EMEA and is indicated to treat severe dyspareunia secondary to vulvovaginal atrophy. The recommended dose of Prasterone is 6.5 mg, administered once daily, at bedtime [184]. Prasterone enters the vaginal cells and is converted intracellularly into small amounts of estrogens and androgens. Activation of the estrogen and androgen receptors affects all three layers of the vaginal wall, including the fibers of the basal membrane collagen and the muscle wall, resulting in a significant improvement of dyspareunia [147]. The distribution of vaginally administered prasterone is mainly local; there is only a slight increase in systemic exposure for its metabolites but within typical postmenopausal values. Serum estradiol rises from 3.33 to 5.04 pg/mL and testosterone, from 12 to 15 ng/dL, therefore remaining within the normal postmenopausal range. Endometrial effects are not clinically significant [185,186].
Expert opinion on existing and developing drugs to treat female sexual dysfunction
Published in Expert Opinion on Emerging Drugs, 2018
Melanie K. Miller, Joshua R. Smith, Jacqueline J. Norman, Anita H. Clayton
Prasterone (Intrarosa) was approved in 2016 to treat dyspareunia caused by VVA in menopausal women and is composed of DHEA (dehydroepiandrosterone), a precursor for the formation of all androgens and estrogens. Prasterone is administered as a vaginal insert, with a recommended dose of 6.5 mg daily, to be used at bedtime. Intravaginal administration of DHEA has the benefit of a local area of action with minimal to no effect on systemic estrogen or testosterone levels, thereby significantly decreasing potential side effects. The most commonly reported side effect is vaginal discharge. Two randomized, double-blind trials comparing intravaginal prasterone to placebo in postmenopausal women with VVA and moderate-to-severe dyspareunia found significant decreases in the degree of dyspareunia. In one 52-week clinical trial, abnormal pap smears were found in 2% of women but may represent early detection with the required pap smears/pelvic exams in the studies [17]. Prasterone is currently not approved to treat HSDD, but given the promising results in this domain, theoretical effects via intracrinology may provide hope for the future. Endoceutics has begun a phase 3 randomized, placebo-controlled trials of 600 postmenopausal women treated with intravaginal prasterone for HSDD [18].
An overview of dehydroepiandrosterone (EM-760) as a treatment option for genitourinary syndrome of menopause
Published in Expert Opinion on Pharmacotherapy, 2020
Michelle Holton, Chelsea Thorne, Andrew T. Goldstein
Prasterone is an intravaginal, local therapy similar to many local estrogen therapies, but has not been compared in a randomized, controlled trial with alternative local and oral therapies [50]. Prasterone does not have box warnings related to systemic absorption and endometrial or mammary tissue proliferation. Multiple ongoing studies are investigating the safety of prasterone for use in postmenopausal patients with breast and gynecologic cancers. The data show that intravaginal prasterone is an effective treatment option for postmenopausal women with moderate to severe dyspareunia and vulvovaginal atrophy. Further double-blind, randomized, controlled trials are needed to compare intravaginal prasterone to alternative systemic and local treatment options.