A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).
Study Type
INTERVENTIONAL
Purpose
PREVENTION
Masking
NONE
Enrollment
169
Sayana Press in the Uniject injection system
Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.
Time frame: Up to 1 year
Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)
Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.
Time frame: Up to 1 year
Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year
Continuation rate for the method at 1 year equals: (\[the number of participants who received all 4 injections and had not discontinued by 12 months\] / \[total number of participants in the study\]) \*100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.
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Time frame: 1 year