Clinical performance of a new two-rod levonorgestrel contraceptive implant: a three-year randomized study with Norplant implants as controls.
In a randomized three-year clinical trial at seven clinics, the performance of levonorgestrel rod (LNG ROD) implants used by 600 women was compared with that of soft tubing NORPLANT implants used by 598 women. No pregnancies occurred in either group of women and, accordingly, body weight did not affect the efficacy of either type of implant. There were neither statistically significant nor important differences in termination rates for any reason over the three years. Complaint and illness rates during use of either of the two implant types were statistically indistinguishable and were attributable to the same set of conditions. Seventy-one per 100 of the women using each implant regimen continued to the three-year point, for an average annual continuation rate of 89 per 100. Removals of LNG ROD implants were accomplished in about half the time required for removal of Norplant capsule implants (p < 0.001).
Sivin
I
I
Center for Biomedical Research, Population Council, New York, NY 10021, USA.
Viegas
O
O
Campodonico
I
I
Diaz
S
S
Pavez
M
M
Wan
L
L
Koetsawang
S
S
Kiriwat
O
O
Anant
M P
MP
Holma
P
P
el din Abdalla
K
K
Stern
J
J
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D002214:Capsules; D002677:Chile / Q000453:epidemiology; D003271:Contraceptive Agents, Female / Q000009:adverse effects / Q000592:standards*; D004343:Drug Implants; D004534:Egypt / Q000453:epidemiology; D005260:Female; D005387:Finland / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D016912:Levonorgestrel / Q000009:adverse effects / Q000592:standards*; D008599:Menstruation Disturbances / Q000139:chemically induced / Q000453:epidemiology; D011247:Pregnancy; D018873:Pregnancy Rate; D012846:Singapore / Q000453:epidemiology; D013785:Thailand / Q000453:epidemiology; D014481:United States / Q000453:epidemiology
D002214:Capsules; D003271:Contraceptive Agents, Female; D004343:Drug Implants; D016912:Levonorgestrel