Abstract
A 2-year trial of a single Nestorone® (NES) rod implant was conducted at three Latin
American centers, each enrolling 100 women. We studied the safety, effectiveness and
acceptability of this progestin-releasing contraceptive implant. Three pregnancies
occurred, the last at 18 months of use. Because no pregnancies were expected in the
first 18 months, the trial was halted. At that time, 224 women had completed at least
18 months of use, and 99 women had used the implant for more than 24 months. Few participants
used adjunctive contraception between the time the study was halted and the time they
had their implant removed. No additional pregnancies occurred before the removal of
the last implant. The 2-year cumulative pregnancy rate was 1.7 per 100 with a Pearl
index of 0.6 per 100 for the 2-year period. The 1-year and 2-year continuation rates
were 80.5 and 66.7 per 100, respectively. Menstrual and medical disturbances were
the principal reasons for discontinuation, followed by planned pregnancy. Headache
and weight gain frequently led to discontinuation. The NES implant had little important
effect on most clinical chemistry and lipid parameters. Over the study course, the
mean change in hemoglobin was <1%. Slight modification of the design of this single
2-year implant, restoring features previously examined in clinical trials, is likely
to improve its effectiveness. A single NES implant appears to provide acceptable contraception
for women.
Keywords
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Article info
Publication history
Accepted:
October 7,
2003
Received in revised form:
September 26,
2003
Received:
July 24,
2003
Footnotes
☆Nestorone® is the registered trademark of the Population Council for 16-methylene-17α-acetoxy-19-nor-pregn-4-ene-3,20-dione.
Identification
Copyright
© 2004 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
