title: The impact of a monophasic continuous estro-progestogenic treatment on Latin American menopausal women.
abstract: OBJECTIVE
  The present study was undertaken to assess the impact, effectiveness and safety of a monophasic hormone replacement treatment (HRT) for continuous use with regards to the clinical effects, bleeding patterns and lipid profile of menopausal women in four Latin American countries.
  
  
  METHODS
  Three hundred and six postmenopausal women with natural menopause and uterus present were recruited. This was a multicentre prospective, clinical trial; the participating countries were Brazil (BR), Colombia (CO), Mexico (MX) and Argentina (AR). The study period was 12 months. The HRT regime was formulated in tablets containing 2 mg estradiol E2 and 1mg norethisterone acetate (NETA); one visit every 3 months was solicited.
  
  
  METHODS
  HRT was given as one tablet every day without interruption for 1 year. Climacteric complaints, side-effects, reason for discontinuation, bleeding patterns, lipid profile at baseline and 12 months of treatment were documented.
  
  
  RESULTS
  There were no significant differences between the four populations on clinical measurements. Thirty-four women discontinued, 13 for bleeding problems. The five most common side-effects were mastalgia, bleeding problems, headache, pelvic pain and nausea. 44.8% of women experienced scanty vaginal bleeding during the first 3 months of therapy. Ninety seven percent of women had amenorrhea at the end of the study in MX, BR and AR, and 100% in CO. Body weight was constant during the study, and no correlation was found between body weight and total days with bleeding. The Kupperman index score was used to evaluate the climacteric complaints, and the score decreased from a mean of 25.4 to 5.1 at 12-months visit. Total cholesterol levels were significantly reduced in BR and CO (P < 0.05) between baseline and the final sample; serum triglycerides remained unchanged, HDL-cholesterol was significantly increased in MX (P < 0.05), and LDL-cholesterol was significantly reduced in CO (P < 0.05). The results of this 1-year study emphasize that a continuous combined HRT regimen with 2 mg E2/1 mg NETA is an attractive alternative for postmenopausal women who are at least 1 year after their menopause and optimally 2 years after their menopause. Although the combination of 2 mg E2 with 1 mg NETA in a continuous combined therapy scheme has been in use in the Nordic countries for over a decade and in Latin America for the last 6 years, there have been no previous published reports on its effectivity in Latin American women. This publication reports the experience in a group of 306 Latin American women, and it is the first Latin American publication with this formulation.
authors.affiliation: University of Coahuila, Calle Gregorio A. Garcia 198 Sur Torreon, Coahuila, Mexico. sbassol@hotmail.com
authors.forename: Susana
authors.initials: S
authors.lastname: Bassol
authors.forename: Sebastian
authors.initials: S
authors.lastname: Carranza-Lira
authors.forename: Cuauhtemoc
authors.initials: C
authors.lastname: Celis-Gonzalez
authors.forename: Samuel
authors.initials: S
authors.lastname: Santoyo
authors.forename: Alfonso
authors.initials: A
authors.lastname: Murillo
authors.forename: Norma
authors.initials: N
authors.lastname: Martinez
authors.forename: Javier
authors.initials: J
authors.lastname: Santos
authors.forename: Victoriano
authors.initials: V
authors.lastname: Llaca
authors.forename: Fernanda Rio
authors.initials: FR
authors.lastname: de la Loza
authors.forename: Jesus
authors.initials: J
authors.lastname: Zarain
authors.forename: Angela Maggio
authors.initials: AM
authors.lastname: da Fonseca
authors.forename: Aroldo F
authors.initials: AF
authors.lastname: Camargos
authors.forename: Edmund C
authors.initials: EC
authors.lastname: Baracat
authors.forename: Marcos F
authors.initials: MF
authors.lastname: da Sá
authors.forename: Juana
authors.initials: J
authors.lastname: Bayo
authors.forename: Liliana
authors.initials: L
authors.lastname: Adaro
authors.forename: Carlos
authors.initials: C
authors.lastname: Gurucharri
authors.forename: Martha
authors.initials: M
authors.lastname: Murga
authors.forename: Nestor
authors.initials: N
authors.lastname: Siseles
authors.forename: Fabiana
authors.initials: F
authors.lastname: Sayegh
authors.forename: Antonio
authors.initials: A
authors.lastname: Tempone
authors.forename: Luis M
authors.initials: LM
authors.lastname: Tempone
authors.forename: Roberto I
authors.initials: RI
authors.lastname: Tozzini
authors.forename: Roberto
authors.initials: R
authors.lastname: Boccanera
authors.forename: Carlos
authors.initials: C
authors.lastname: Naranjo
authors.forename: Fabio
authors.initials: F
authors.lastname: Sanchez
authors.forename: Gustavo
authors.initials: G
authors.lastname: Gomez
authors.forename: Stella
authors.initials: S
authors.lastname: Blanco
authors.forename: Roberto
authors.initials: R
authors.lastname: Reyes-Marquez
authors.forename: Gerhard
authors.initials: G
authors.lastname: Albrecht
authors.forename: Pedro Cano
authors.initials: PC
authors.lastname: Rios
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001007:Anxiety / Q000188:drug therapy; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*; D003863:Depression / Q000188:drug therapy; D004244:Dizziness / Q000188:drug therapy; D004958:Estradiol / Q000009:adverse effects / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D005260:Female; D006261:Headache / Q000188:drug therapy; D006339:Heart Rate / Q000187:drug effects; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007843:Latin America; D008055:Lipids / Q000097:blood; D008593:Menopause; D008875:Middle Aged; D018908:Muscle Weakness / Q000188:drug therapy; D009640:Norethindrone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077563:Norethindrone Acetate; D010292:Paresthesia / Q000188:drug therapy; D011446:Prospective Studies
chemical_list: D003280:Contraceptives, Oral, Synthetic; D008055:Lipids; D004958:Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone