The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
508
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser without reminder support
Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time
Time frame: 12 months
Number of delayed and missed pills
Time frame: 12 months
Bleeding pattern and cycle control parameters
Time frame: 12 months
Length of the tablet break and the length of the bleeding episode preceding the tablet break
Time frame: 12 months
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Unnamed facility
Paris, Paris, France
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Biarritz, France
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Marly-le-Roi, France
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Nancy, France
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Olivet, France
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Paris, France
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Paris, France
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Paris, France
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Strasbourg, France
Unnamed facility
Toulouse, France
...and 33 more locations