Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant.
Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.
Coutinho
E M
EM
Maternidade Climerio de Oliveira, Federal University of Bahia, Salvador, Brazil.
de Souza
J C
JC
Athayde
C
C
Barbosa
I C
IC
Alvarez
F
F
Brache
V
V
Gu
Z P
ZP
Emuveyan
E E
EE
Adekunle
A O
AO
Devoto
L
L
Shaaban
M M
MM
Salem
H T
HT
Affandi
B
B
de Acosta
O M
OM
Mati
J
J
Ladipo
O A
OA
D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D004343:Drug Implants; D005260:Female; D006801:Humans; D008535:Megestrol; D009649:Norpregnadienes / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D045167:Progesterone Congeners / Q000008:administration & dosage / Q000009:adverse effects; D014592:Uterine Hemorrhage / Q000139:chemically induced
D003271:Contraceptive Agents, Female; D004343:Drug Implants; D009649:Norpregnadienes; D045167:Progesterone Congeners; C038501:nomegestrol acetate; D008535:Megestrol