Researchers have cautioned against generalizing results from contraceptive
trials because these studies rely on self-selected participants meeting str
ict selection criteria who may differ from typical users. Using information
collected on daily diaries, we reanalyzed data from the recently completed
Reality(R) female condom clinical trial to evaluate factors that influence
the probability of pregnancy. Noncompliant women, women with less variable
menstrual cycles (17-43 days), and women engaging in intercourse frequentl
y (greater than or equal to 11 acts per month) were more likely: to conceiv
e during this 8-month trial. The adjusted hazard ratios and 95% confidence
intervals for these three covariates were 6.1 (2.0-18.7), 7.2 (1.0-54.3), a
nd 2.0 (0.7-5.3), respectively The strict selection criteria used in this s
tudy failed to recruit a homogeneous cohort with respect to factors that in
fluence the risk of pregnancy. The overall pregnancy rate does not pertain
to individual study participants, but rather represent average effects for
a population with the particular mix of characteristics found in this study
. In particular, we not only confirm the well known importance of complianc
e and the obvious role of frequency of intercourse, but also demonstrate th
at women with cycles outside the range of 17-43 days appear to be at a much
lower risk of pregnancy.