Contraception with two levonorgestrel rod implants. A 5-year study in the United States and Dominican Republic.
A 5-year trial of a two-rod contraceptive implant, which releases the progestin levonorgestrel (LNG rod), was conducted at four clinics with 594 women. Mean age and weight at admission were 25.5 years and 62.4 kg, respectively. Consent to continue through 5 years was sought and obtained when the 3-year cumulative pregnancy rate proved to be 0.8 per 100. No pregnancies occurred in the fourth or fifth years. The 5-year cumulative pregnancy rate was, therefore, 0.8 per 100 with an annual average pregnancy rate below 2 per 1000 women. Prolonged bleeding/spotting (8.2% of subjects) and irregular bleeding (5.6%) were the most frequently cited medical reasons for removal. Removals for headache (4.7%) and weight change (4.0%) were the next most frequent medical reasons. Between 1% and 2% of subjects during the 5-year trial sought removals for each of the following conditions: mood changes, lower abdominal pain, depression, or pain at the implant site. The mean annual continuation rate during the study was 77 per 100. Use per woman averaged 2.96 years. Mean removal time was 5.9 +/- 0.6 min. These data indicate that, for a 5-year period, the two LNG rod implants are equivalent to the six Norplant capsule implants with respect to safety and efficacy parameters, but permit easier and more rapid implant removal.
Sivin
I
I
Center for Biomedical Research, Population Council, New York, New York 10021, USA.
Alvarez
F
F
Mishell
D R
DR
Darney
P
P
Wan
L
L
Brache
V
V
Lacarra
M
M
Klaisle
C
C
Stern
J
J
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D004293:Dominican Republic; D004343:Drug Implants; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000009:adverse effects*; D008599:Menstruation Disturbances / Q000209:etiology; D011247:Pregnancy; D014481:United States
D003271:Contraceptive Agents, Female; D004343:Drug Implants; D016912:Levonorgestrel