title: Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17β-estradiol/progesterone.
abstract: OBJECTIVE
  To evaluate the short term effect over menopausal symptoms and quality of life (QoL) of monthly parenteral formulations of 17β-estradiol (E)/progesterone (P) non-polymeric microspheres.
  
  
  METHODS
  This is a secondary analysis of a multicenter, randomized, single-blinded study that included peri- and post-menopausal symptomatic women assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24), or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Intensity of menopausal symptoms was assessed before and after treatment with the Greene Climacteric Scale (GCS) and QoL with the Utian Quality of Life Scale (UQoLS).
  
  
  RESULTS
  Menopausal symptoms improved for all groups at six months evidenced by lower cluster/sub-cluster GCS scores. Equally, there was an overall trend for QoL improvement for all groups evidenced by higher domain UQoLS scores at six months; but only significant for the emotional (Groups A and B) and occupational domains (Groups A and C).
  
  
  CONCLUSIONS
  The three low-dose continuous sequential intramuscular monthly formulations of E/P microspheres exerted a positive effect over menopausal symptoms and QoL. Long-term research is warranted with these formulations.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifiers NCT 00775242.
authors.affiliation: a Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes" , Ciudad de México , México.
authors.forename: Manuel
authors.initials: M
authors.lastname: Cortés-Bonilla
authors.affiliation: b Centro A.F. de Estudios Tecnológicos , S.A. de C.V. (CAFET), Ciudad de México , México.
authors.forename: Rosalba
authors.initials: R
authors.lastname: Alonso-Campero
authors.affiliation: b Centro A.F. de Estudios Tecnológicos , S.A. de C.V. (CAFET), Ciudad de México , México.
authors.forename: Roberto
authors.initials: R
authors.lastname: Bernardo-Escudero
authors.affiliation: b Centro A.F. de Estudios Tecnológicos , S.A. de C.V. (CAFET), Ciudad de México , México.
authors.forename: María T
authors.initials: MT
authors.lastname: Francisco-Doce
authors.affiliation: b Centro A.F. de Estudios Tecnológicos , S.A. de C.V. (CAFET), Ciudad de México , México.
authors.forename: Juan
authors.initials: J
authors.lastname: Chavarín-González
authors.affiliation: c Unidad de Investigación Epidemiológica y en Servicios de Salud, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social , Ciudad de México , México , and.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Pérez-Cuevas
authors.affiliation: d Facultad de Ciencias Médicas , Instituto de Biomedicina, Área de Investigación para la Salud de la Mujer, Universidad Católica de Santiago de Guayaquil , Guayaquil , Ecuador.
authors.forename: Peter
authors.initials: P
authors.lastname: Chedraui
mesh_terms: D000328:Adult; D000368:Aged; D004958:Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D012739:Gonadal Steroid Hormones / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D007273:Injections, Intramuscular; D008593:Menopause / Q000187:drug effects*; D008863:Microspheres; D008875:Middle Aged; D011374:Progesterone / Q000008:administration & dosage / Q000494:pharmacology*; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D012739:Gonadal Steroid Hormones; D011374:Progesterone; D004958:Estradiol
keywords: Climacteric; Greene Climacteric Scale; Utian Quality of Life Scale; estradiol; menopausal symptoms; non polymeric microspheres; quality of life