The impact of a monophasic continuous estro-progestogenic treatment on Latin American menopausal women.
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.
Bassol
Susana
S
University of Coahuila, Calle Gregorio A. Garcia 198 Sur Torreon, Coahuila, Mexico. sbassol@hotmail.com
Carranza-Lira
Sebastian
S
Celis-Gonzalez
Cuauhtemoc
C
Santoyo
Samuel
S
Murillo
Alfonso
A
Martinez
Norma
N
Santos
Javier
J
Llaca
Victoriano
V
de la Loza
Fernanda Rio
FR
Zarain
Jesus
J
da Fonseca
Angela Maggio
AM
Camargos
Aroldo F
AF
Baracat
Edmund C
EC
da Sá
Marcos F
MF
Bayo
Juana
J
Adaro
Liliana
L
Gurucharri
Carlos
C
Murga
Martha
M
Siseles
Nestor
N
Sayegh
Fabiana
F
Tempone
Antonio
A
Tempone
Luis M
LM
Tozzini
Roberto I
RI
Boccanera
Roberto
R
Naranjo
Carlos
C
Sanchez
Fabio
F
Gomez
Gustavo
G
Blanco
Stella
S
Reyes-Marquez
Roberto
R
Albrecht
Gerhard
G
Rios
Pedro Cano
PC
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
D003280:Contraceptives, Oral, Synthetic; D008055:Lipids; D004958:Estradiol; D000077563:Norethindrone Acetate; D009640:Norethindrone