Efficacy of vaginally applied estrogen, testosterone, or polyacrylic acid on vaginal atrophy: a randomized controlled trial

Objective:Vaginal atrophy is a common chronic condition among postmenopausal women that can affect their quality of life. Recent studies have evaluated new treatment alternatives for vaginal atrophy; however, few therapeutic options have been thoroughly evaluated. This study aimed to compare the effectiveness and adverse effects of estrogen, testosterone, polyacrylic acid, and placebo lubricant for the treatment of postmenopausal women with vaginal atrophy. Methods:We conducted a randomized clinical trial with 80 postmenopausal women aged between 40 and 70 years who were being followed up at the Menopause Clinic of CAISM UNICAMP between November 2011 and January 2013. Women were randomly assigned to topical vaginal treatment with estrogen, testosterone, polyacrylic acid, and placebo lubricant, three times a week for 12 weeks. We used the vaginal maturation index, pH, vaginal health score, vaginal flora, laboratory tests, and ultrasound to evaluate changes of vaginal atrophy at baseline and after 6 and 12 weeks of treatment. Results:After a 12-week treatment with topical estrogen and testosterone compared with the lubricant, an increased percentage of participants had vaginal pH less than 5, increased vaginal score, and an increase in the number of lactobacilli. Treatment with topical estrogen improved the vaginal maturation index and showed increased levels of estradiol in three women. No changes were observed in the endometrial evaluation of all treatment groups. Conclusions:After a 12-week treatment with testosterone and estrogen compared with placebo lubrication, there was a significant improvement in vaginal trophism in postmenopausal women with vaginal atrophy.

[1]  Jacques Ravel,et al.  Association between the vaginal microbiota, menopause status, and signs of vulvovaginal atrophy , 2018, Menopause.

[2]  A. Pinto-Neto,et al.  Efficacy of vaginally applied estrogen, testosterone, or polyacrylic acid on sexual function in postmenopausal women: a randomized controlled trial. , 2014, The journal of sexual medicine.

[3]  S. Kingsberg,et al.  Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. , 2013, The journal of sexual medicine.

[4]  A. Perrone,et al.  Androgen receptor expression in the human vagina under different physiological and treatment conditions , 2013, International Journal of Impotence Research.

[5]  Jean M. Macklaim,et al.  Vaginal Microbiome and Epithelial Gene Array in Post-Menopausal Women with Moderate to Severe Dryness , 2011, PloS one.

[6]  B. Littenberg,et al.  Topical testosterone for breast cancer patients with vaginal atrophy related to aromatase inhibitors: a phase I/II study. , 2011, The oncologist.

[7]  L. Derogatis,et al.  Safety and efficacy of low-dose esterified estrogens and methyltestosterone, alone or combined, for the treatment of hot flashes in menopausal women: a randomized, double-blind, placebo-controlled study. , 2011, Fertility and sterility.

[8]  C. Stika Atrophic vaginitis , 2010, Dermatologic therapy.

[9]  P. Dubey,et al.  A comparative study of the effects of local estrogen with or without local testosterone on vulvovaginal and sexual dysfunction in postmenopausal women. , 2010, The journal of sexual medicine.

[10]  C. Labrie,et al.  Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy , 2009, Menopause.

[11]  K. Reape,et al.  Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy , 2009, Menopause.

[12]  C. Labrie,et al.  Effect of one-week treatment with vaginal estrogen preparations on serum estrogen levels in postmenopausal women , 2009, Menopause.

[13]  A. Ewies,et al.  Topical estrogen therapy in the management of postmenopausal vaginal atrophy: an up-to-date overview , 2009, Climacteric : the journal of the International Menopause Society.

[14]  R. Ferriani,et al.  The effects of hypoestrogenism on the vaginal wall: interference with the normal sexual response. , 2009, The journal of sexual medicine.

[15]  G. Braunstein,et al.  Testosterone for low libido in postmenopausal women not taking estrogen. , 2008, The New England journal of medicine.

[16]  A. Grossman,et al.  The incidentally discovered adrenal mass. , 2007, The New England journal of medicine.

[17]  G. Bachmann,et al.  The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of The North American Menopause Society , 2007, Menopause.

[18]  I. Goldstein,et al.  Differential regulation of the expression of estrogen, progesterone, and androgen receptors by sex steroid hormones in the vagina: immunohistochemical studies. , 2006, The journal of sexual medicine.

[19]  C. Castelo-Branco,et al.  Management of post-menopausal vaginal atrophy and atrophic vaginitis. , 2005, Maturitas.

[20]  F. Labrie,et al.  Effects of dehydroepiandrosterone, Premarin and Acolbifene on histomorphology and sex steroid receptors in the rat vagina , 2005, The Journal of Steroid Biochemistry and Molecular Biology.

[21]  C. Castelo-Branco,et al.  Low-dose, vaginally administered estrogens may enhance local benefits of systemic therapy in the treatment of urogenital atrophy in postmenopausal women on hormone therapy. , 2005, Maturitas.

[22]  A. Lethaby,et al.  Local oestrogen for vaginal atrophy in postmenopausal women. , 2003, The Cochrane database of systematic reviews.

[23]  J. A. van der Laak,et al.  The effect of Replens on vaginal cytology in the treatment of postmenopausal atrophy: cytomorphology versus computerised cytometry. , 2002, Journal of clinical pathology.

[24]  G. Gorodeski Vaginal-cervical epithelial permeability decreases after menopause. , 2001, Fertility and sterility.

[25]  M. Bygdeman,et al.  Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women. , 1996, Maturitas.

[26]  B. Risberg,et al.  The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. , 1995, Maturitas.

[27]  L. Nachtigall Comparative study: Replens versus local estrogen in menopausal women. , 1994, Fertility and sterility.

[28]  K. Holmes,et al.  Diagnosis of bacterial vaginosis by direct gram stain of vaginal fluid , 1983, Journal of clinical microbiology.

[29]  A. Meisels The maturation value. , 1967, Acta cytologica.