Mesigyna once-a-month combined injectable contraceptive: experience in Latin America.
A phase III clinical study was carried out among 534 fertile Latin American women to evaluate cycle control, side effects, and contraceptive efficacy of a once-a-month combined injectable, Mesigyna, consisting of 50 mg norethisterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 year was 0 per 100 woman-years for a total experience of 4688 woman-months. The overall discontinuation rate at one year was 17.9%. Discontinuation rate for bleeding problems was 5.1%. The Colombian women had a significant increase (p <0.001) in bleeding problems compared to other countries. The discontinuation rate for amenorrhea was 1.1%. There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna is an appropiate once-a-month injectable contraceptive for Latin American women since it is highly effective and its perception of normal menstrual bleeding is of importance in the Latin American population.
Bassol
S
S
Centro de Investigacion Biomedica Universidad, Autonoma de Coahuila, Mexico. sbassol@hotmail.com
Cravioto
M C
MC
Durand
M
M
Bailon
R
R
Carranza
S
S
Fugarolas
J
J
Gaona
R
R
Parada
L M
LM
Celis
C
C
Santoyo
S
S
Garza-Flores
J
J
Vazquez
L
L
Lopez
C
C
Gurucharri
C
C
Novelli
J
J
Carneiro de Oliveira
H
H
Mendez
J
J
de Andrade
M E
ME
de Mello
N R
NR
de Melo
K
K
Chada
E
E
Yassle
M E
ME
Castañeda
A
A
Gomez
P
P
Arboleda
C
C
Trujillo
L
L
Bucheli
R
R
Hidalgo
I
I
Olavide
R
R
Parejarios
J
J
Succar
J
J
Reyes-Marquez
R
R
Albrecht
G
G
D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D001794:Blood Pressure; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D004958:Estradiol / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007267:Injections; D007843:Latin America; D009640:Norethindrone / Q000031:analogs & derivatives*; D011247:Pregnancy; D014592:Uterine Hemorrhage / Q000139:chemically induced; D015430:Weight Gain
D003271:Contraceptive Agents, Female; D004338:Drug Combinations; C418365:estradiol, norethindrone drug combination; D004958:Estradiol; D009640:Norethindrone