Clinical trial NCT04017195: A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women
Official title: A Randomized, Double-blind, 2-Way Crossover Bioequivalence and Adhesion Study of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components at the End of Shelf Life and Currently Marketed EVRA® at the Beginning of Shelf Life in Healthy Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The main objectives of this study are to determine the bioequivalence of the hormones (example, norelgestromin \[NGMN\] and ethinyl estradiol \[EE\]) from the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component and show non-inferior adhesion of the transdermal contraceptive patch using the newly sourced adhesive component as compared to the currently marketed EVRA patch using the adhesive component.


Eligibility criteria: Inclusion Criteria:

* Participant has a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2), inclusive, and body weight not less than 50 kilogram (kg) and not more than 100 kg at screening
* Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing a highly effective method (that is, failure rate of less than \[\<\] 1 percent \[%\] per year) of non hormonal contraception (example, intrauterine device \[IUD\], male partner sterilization) before admission and throughout the study
* Participant has a blood pressure (after the participant is supine or sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
* Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: Normal sinus rhythm with heart rate between 45 and 100 beats per minute (bpm), extremes included; QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) =\<470 millisecond (ms); QRS interval =\<120 ms; PR interval =\<220 ms. ECG morphology consistent with healthy cardiac conduction and function. Any evidence of heart block and left or right bundle branch block is exclusionary
* Participant must be a non-smoker, ex-smoker for greater than (\>) 6 months, must not use nicotine containing substances including tobacco products (example, cigarettes, e-cigarettes. cigars, chewing tobacco, gum, patch), or tests negative for cotinine at screening and on Day 1 of each treatment period

Exclusion Criteria:

* Participant has clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
* Participant has abnormal thyroid stimulating hormone level at screening
* Participant has evidence of cervical dysplasia as documented by a CytoRich test or Papanicolaou (PAP) smear test within 10 months before screening. If a PAP smear has been done within 10 months prior to screening and results are available (documentation is available at the study site) a cervical smear does not need to be performed
* Participant has used oral hormonal contraception, that is, contraceptive pills, within 3 months before admission to the study site on Day -1 of Treatment Period 1
* Participant currently has a contraceptive implant such as Implanon or Norplant in place, or has had removal of contraceptive implant within the 3 months before admission to the study site on Day -1 of Treatment Period 1

Primary outcomes:
measure: Mean Steady-State Concentration (Css) of Norelgestromin (NGMN)
timeFrame: 48 to 168 hours post-dose
measure: Mean Steady-State Concentration (Css) of Ethinyl Estradiol (EE)
timeFrame: 48 to 168 hours post-dose
measure: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of NGMN
timeFrame: Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
measure: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of EE
timeFrame: Predose, 24, 48, 72, 96, 120, 144, 168, 168.5, 171, 174, 180, 192, 216 and 240 hours post dose
measure: Area Under the Plasma Concentration-Time Curve from Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of NGMN
timeFrame: Pre-dose to 168 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) of EE
timeFrame: Pre-dose to 168 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of NGMN
timeFrame: Pre-dose to 240 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) of EE
timeFrame: Pre-dose to 240 hours post-dose
measure: Cumulative Adhesion Percentage Ratio
timeFrame: Baseline (Day 1) and every 24 hours after patch application up to patch removal at 168 hours (Day 8)]
measure: Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for NGMN
timeFrame: Pre-dose to 240 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for EE
timeFrame: Pre-dose to 240 hours post-dose
Secondary outcomes:
measure: Percentage of Participants with Specific Application Site Reactions
timeFrame: Pre-dose, 168.5, and 192 hours post-dose
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 97 Days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Belgium NV
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin (CCM)
city: Groningen
country: Netherlands
facility: PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: