Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study

Abstract

OBJECTIVE:To determine the safety and efficacy of a transdermal nanostructured formulation of progesterone (10%) combined with estriol (0.1%) + estradiol (0.25%) for relieving postmenopausal symptoms.METHODS:A total of 66 postmenopausal Brazilian women with climacteric symptoms of natural menopause received transdermal nanostructured formulations of progesterone and estrogens in the forearm daily for 60 months to mimic the normal ovarian secretory pattern. Confocal Raman spectroscopy of hormones in skin layers was performed. Clinical parameters, serum concentrations of estradiol and follicle-stimulating hormone, blood pressure, BI-RADS classification from bilateral mammography, and symptomatic relief were compared between baseline and 60 months post-treatment. Clinicaltrials.gov: NCT02033512.RESULTS:An improvement in climacteric symptoms was reported in 92.5% of women evaluated before and after 60 months of treatment. The serum concentrations of estradiol and follicle-stimulating hormone changed significantly (p<0.05) after treatment; the values of serum follicle-stimulating hormone decreased after 60 months from 82.04±4.9 to 57.12±4.1 IU/mL. A bilateral mammography assessment of the breasts revealed normal results in all women. No adverse health-related events were attributed to this hormone replacement therapy protocol.CONCLUSION:The nanostructured formulation is safe and effective in re-establishing optimal serum levels of estradiol and follicle-stimulating hormone and relieving the symptoms of menopause. This transdermal hormone replacement therapy may alleviate climacteric symptoms in postmenopausal women.

Transdermal hormone replacement therapy with nanostructured medicines

“…The efficacy of MNPEE in reducing the frequency of hot flushes was significantly higher than that of placebo at from weeks three to 12. At the 12 th week, MNPEE could decrease the daily frequency of hot flushes by 11.1 times Botelho, 2014 [21] Title: Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study Type of study: Long-term clinical trial Participants: 66 postmenopausal women with climacteric syndrome Study design: In order to provide a hormone secretion pattern similar to that of normal ovaries, the participants were asked to apply transdermal nanostructured progesterone and estrogen formulations on their forearms every day for 60 months. The assessment of hormones in different skin layers was conducted using confocal Raman spectroscopy.…”

“…Botelho et al reported the use of nanoparticles in transdermal HRT as a safe and efficient controlled drug release system to alleviate menopausal symptoms [21]. In another study, Botelho et al evaluated the efficacy of a novel transdermal delivery system using a nanostructured formulation containing testosterone and progesterone.…”

“…As a result of increasing attention to nanotechnology in dealing with health challenges faced by the older population [20], great advances have been made in the design of nanoformulation for various conditions including breast cancer, hearing loss, and cardiovascular and central nervous system diseases [19]. New evidence has also suggested the unique properties of nanostructured HRT in the management of climacterium symptoms [21]. However, since the exact benefits of such protocols are still under debate, the present study reviewed different aspects of nanostructured HRT and its applications in alleviating menopausal symptoms.…”

Effects of a transdermal testosterone metered-dose nanoemulsion in peri- and postmenopausal women: a novel protocol for treating low libido

“…7,9 This new technology is present in many fields in medical science and it has been proving to be a strong allied with unique properties for drugs delivery and physiologic absorption. 10,11 Over the years, there has been an increasing interest regarding the determination of which symptoms could be used to precisely define testosterone deficiency in women.…”

“…Is it well established that postmenopausal women continue to be sexually active despite sexual complaints. [2][3][4][5][6][7][8][9][10][11][12][13] Sexual activity is a useful tool to maintain a healthy life. Women were allocated to this study if they reported significant loss of sexual desire.…”