title: 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.
  
  
  CONCLUSIONS
  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.
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Marco Antonio
authors: MA
authors: Botelho
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Dinalva Brito
authors: DB
authors: Queiroz
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Gisele
authors: G
authors: Barros
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Stela
authors: S
authors: Guerreiro
authors: Federal University of Ceará, Department of Analytical Chemistry, Group of Advanced Biomaterial in Chemistry (GQMAT), FortalezaCE, Brazil, Federal University of Ceará, Department of Analytical Chemistry, Group of Advanced Biomaterial in Chemistry (GQMAT), Fortaleza/CE, Brazil.
authors: Pierre
authors: P
authors: Fechine
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Sonia
authors: S
authors: Umbelino
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Arão
authors: A
authors: Lyra
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Boniek
authors: B
authors: Borges
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Allan
authors: A
authors: Freitas
authors: Federal Institute of Science and Technology of Ceará, Laboratory of Biotechnology, FortalezaCE, Brazil, Federal Institute of Science and Technology of Ceará, Laboratory of Biotechnology, Fortaleza/CE, Brazil.
authors: Danilo Caldas de
authors: DC
authors: Queiroz
authors: University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
authors: Ronaldo
authors: R
authors: Ruela
authors: Federal Institute of Science and Technology of Ceará, Laboratory of Biotechnology, FortalezaCE, Brazil, Federal Institute of Science and Technology of Ceará, Laboratory of Biotechnology, Fortaleza/CE, Brazil.
authors: Jackson Guedes
authors: JG
authors: Almeida
authors: Federal University of Sergipe, Department of Physiology, São CristóvãoSE, Brazil, Federal University of Sergipe, Department of Physiology, São Cristóvão/SE, Brazil.
authors: Lucindo
authors: L
authors: Quintans
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D004338:Drug Combinations; D004958:Estradiol / Q000097:blood / Q000627:therapeutic use*; D004964:Estriol / Q000627:therapeutic use*; D004967:Estrogens / Q000627:therapeutic use*; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008855:Microscopy, Electron, Scanning; D008875:Middle Aged; D010316:Particle Size; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology; D011374:Progesterone / Q000627:therapeutic use*; D011446:Prospective Studies; D012867:Skin / Q000187:drug effects; D013059:Spectrum Analysis, Raman; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D004967:Estrogens; D011374:Progesterone; D004958:Estradiol; D005640:Follicle Stimulating Hormone; D004964:Estriol