Contraception Clinical Trial
Official title:
Open-Label, Randomized, Partially Balanced, Incomplete Block Design Study to Evaluate the Hormone Exposure From Commercial EVRA (Manufactured by LOHMANN Therapie-Systeme) and an Oral Contraceptive
The objective of this study is to estimate exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial lots of EVRA® (a transdermal contraceptive patch manufactured by LOHMANN Therapie-Systeme), to compare these data to exposure data from one clinical lot, and to compare these data to exposure data from a commercially available oral contraceptive.
This single-center, open-label, randomized, partially-balanced, incomplete block design
study will consist of a pre-treatment phase (a screening period lasting up to 21 days), an
open-label treatment phase (three 7-day treatment periods separated by 21-day washouts), and
a post-treatment phase (a follow-up or early withdrawal visit). Total participation in the
study is approximately 67 days. Approximately 54 subjects will be enrolled. The study
population comprises healthy women, ages 18 to 45 years inclusive, who weigh at least 110
pounds, have a body mass index (BMI) between 16 and 29.9 kg per meter squared.
Subjects will wear an EVRA® patch or take CILEST® during each of the three 7-day treatment
periods; treatment periods will be separated by a 21-day washout period. When a subject is
to wear EVRA®, a patch from 1 of the 6 selected commercial lots will be applied on the
buttock and worn for 7 days. Patches will be applied by the investigator or designated study
unit personnel. All patches will be worn on the upper outer quadrant of the same buttock,
but not necessarily in the exact same position. The investigator or designated study unit
personnel will remove the patches and will evaluate the adhesion of the patches before
removal. When a subject is to receive CILEST®, tablets from 1 of the 3 selected commercial
lots will be administered daily for 7 consecutive days. A minimum of 21 days after removal
of the patch or the seventh dose of CILEST®, the subject will begin another treatment
period, until she completes 3 open-label treatment periods.
Subjects will be confined to the study unit for blood sample collections for determination
of NGMN, NG, and EE plasma concentrations. Blood samples will be collected (via
venipuncture) immediately before each dose and at specified time points after each dose is
administered. Pharmacokinetic parameters of NGMN, NG, and EE, including Cmax, tmax, and AUC,
after each treatment will be estimated by standard methods. Safety will be assessed
throughout the study, and will be based on adverse events and changes in physical and
gynecologic examinations (including breast examinations), vital signs, electrocardiograms
(ECGs), and clinical laboratory test results. Three 7-day treatment periods; treatments
separated by 21-day washout. Based on the randomization schedule, some subjects will wear an
EVRA® patch in all 3 periods (on the upper outer quadrant of the buttock for 7 days), some
will wear a patch in 2 periods and take CILEST® oral tablets once daily in 1 period, and
some will wear a patch in 1 period and take CILEST® oral tablets once daily in 2 periods.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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