Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT03274297
The purpose of this study is to determine the bioequivalence of the hormones (ie, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch and to evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component, as compared to the currently marketed EVRA patch.
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Notify Me18 year–45 year
Female
Interventional
Phase 4
Merksem, 2170, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single transdermal contraceptive patch of EVRA (NGMN + EE) containing 6 milligram (mg) of the progestin NGMN and 600 microgram (mcg) of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.
Other names: RWJ10553
A single transdermal contraceptive HMW PIB (NGMN + EE) patch containing 6 mg of the progestin NGMN and 600 mcg of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.
Other names: RWJ10553
Time frame: 48 to 168 hours post-dose
Mean steady-state concentration for NGMN after patch application, will be calculated as the mean concentration between 48 hours and 168 hours after patch application.
Time frame: 48 to 168 hours post-dose
Mean steady-state concentration for EE after patch application, will be calculated as the mean concentration between 48 hours and 168 hours after patch application.
Time frame: Pre-dose to 168 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 168 hours of NGMN in plasma will be assessed.
Time frame: Pre-dose to 168 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 168 hours of EE in plasma will be assessed.
Time frame: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 240 hours of NGMN in plasma will be assessed.
Time frame: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to 240 hours of EE in plasma will be assessed.
Time frame: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to infinite time of NGMN in plasma will be assessed.
Time frame: Pre-dose to 240 hours post-dose
Area under the concentration versus time curve from zero (patch application) to infinite time of EE in plasma will be assessed.
Time frame: Baseline (Day 1) and every 24 hours after patch application up to patch removal at 168 hours (Day 8)
Adhesion of patches will be assessed in accordance with the European Medicines Agency (EMA) 0-5 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (EMA 0-5 [percentage (%)] scoring). Estimated percentages of adhesion and corresponding EMA 0-5 score at each interval will be recorded in each participant's electronic case report form. The scoring system for adhesion of transdermal patches is indicated as follows: 0= greater than (>) 90-100% of the patch area adheres; 1= >80-90% of the patch area adheres; 2= >70-80% of the patch area adheres; 3= >60-70% of the patch area adheres; 4= >50-60% of the patch area adheres; 5= 0-less than or equal to (<=) 50% of the patch area adheres.
Time frame: Screening, pre-dose, 168.5 and 192 hours post-dose
Percentage of participants with specific application site reactions will be summarized for each treatment.
Janssen Research & Development, LLC
Industry
A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA® in Healthy Adult Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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