Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs).
The primary objective was to evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3 consecutive cycles of administration of each treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
pregnancy prevention
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Pembroke Pines, Florida, United States
Ovulation Suppression in Three Treatment Groups Over 3 Cycles
Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are: Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points. Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points. Perfect compliance: If no patch has been off \>1 day and no more than 1 day has elapsed between patch changes. Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit.
Time frame: 3 months
Cycle Control
The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Sandy Springs, Georgia, United States
Unnamed facility
Cary, North Carolina, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Jenkintown, Pennsylvania, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
...and 1 more locations