A study to assess the contraceptive effectiveness of Sino-implant (II).
Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and Jadelle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
650
LNG containing subdermal contraceptive implant
LNG containing subdermal contraceptive implant
Profamilia
Santo Domingo, Dominican Republic
Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use.
Pearl Index (number of pregnancies per 100 woman-years) over 4 years of use of Sino-implant (II).
Time frame: 4 years
Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use
Pearl Index over 5 years of use of Sino-implant (II) ; continuation \& reasons for discontinuation in both groups.
Time frame: 5 years
Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle
annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II);
Time frame: 5 years
Compare pharmacokinetic profiles of Sino-implant (II) and Jadelle during the first 6 months of use in a sub-group of users undergoing intensive levonorgestrel sampling
The PK profile of LNG during the first 6 months post-insertion including the following parameters in a sub-group of users undergoing intensive LNG sampling: Mean LNG concentrations at 6 hours, 24 hours, 48 hours, 72 hours, 7 days and 90 days post-insertion Concentration-time profiles of LNG (individual and pooled) Maximal concentration (Cmax) and time to maximal concentration (Tmax) AUC0-7 days, AUC0-1mon, AUC0-3mon and AUC0-6mon
Time frame: 5 years
Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use
Adverse event rates in both treatment groups Annual and cumulative probability of early discontinuation in both treatment groups Reasons for discontinuation in both treatment groups Responses on acceptability questionnaires in both treatment groups
Time frame: 5 years
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Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users.
free levonorgestrel index, estimated as the ratio of levonorgestrel to sex hormone binding globulin at various point during 5 years of product use in a sub-group of approximately 150 women.
Time frame: 5 years