This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 11 of 27 for:    ortho evra

A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified September 2017 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT03274297
First received: September 5, 2017
Last updated: NA
Last verified: September 2017
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Healthy Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference) Drug: HMW PIB patch (NGMN+EE) (Treatment B) (Test) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Mean Steady-State Concentration (Css) for Norelgestromin (NGMN) [ 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.

  • Mean Steady-State Concentration (Css) for Ethinyl Estradiol (EE) [ 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.

  • Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) for NGMN [ 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.

  • Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 168 hours Post-dose (AUC[0-168]) for EE [ 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.

  • Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) for NGMN [ 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.

  • Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Time 240 hours Post-dose (AUC[0-240]) for EE [ 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.

  • Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for NGMN [ 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.

  • Area Under the Plasma Concentration-Time Curve From Time 0 (Patch Application) to Infinite Time (AUC[0-infinity]) for EE [ 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.

  • Cumulative Adhesion Percentage Ratio [ 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.


Secondary Outcome Measures:
  • Irritation Potential [ 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.


Estimated Enrollment: 68
Anticipated Study Start Date: September 5, 2017
Estimated Study Completion Date: April 26, 2018
Estimated Primary Completion Date: April 26, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Sequence AB (Right/Left)
A single patch of currently marketed EVRA patch (Treatment A) will be applied to the right buttock of participants on Day 1 of treatment period 1, followed by application of a single patch of transdermal contraceptive using the newly sourced adhesive component HMW PIB (Treatment B) to left buttock of participants on Day 1 of treatment period 2. The treatment periods will be separated by a washout period of 21 days.
Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)
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 Name: RWJ10553
Drug: HMW PIB patch (NGMN+EE) (Treatment B) (Test)
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 Name: RWJ10553
Experimental: Group 2: Sequence BA (Right/Left)
Treatment B will be applied to the right buttock of participants on Day 1 in Period 1 followed by Treatment A to the left buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)
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 Name: RWJ10553
Drug: HMW PIB patch (NGMN+EE) (Treatment B) (Test)
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 Name: RWJ10553
Experimental: Group 3: Sequence AB (Left/Right)
Treatment A will be applied to the left buttock of participants on Day 1 in Period 1 followed by Treatment B to the right buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)
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 Name: RWJ10553
Drug: HMW PIB patch (NGMN+EE) (Treatment B) (Test)
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 Name: RWJ10553
Experimental: Group 4: Sequence BA (Left/Right)
Treatment B will be applied to the left buttock of participants on Day 1 in Period 1 followed by Treatment A to the right buttock on Day 1 in Period 2. The treatment periods will be separated by a washout period of 21 days.
Drug: EVRA patch (NGMN+EE) (Treatment A) (Reference)
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 Name: RWJ10553
Drug: HMW PIB patch (NGMN+EE) (Treatment B) (Test)
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 Name: RWJ10553

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 to exceed 100 kilogram
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This will be documented and signed by the investigator in the source document
  • Participant must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening and negative urine pregnancy tests on Day -1 of each treatment period
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Participant must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing an effective method of non-hormonal birth control (example [eg], intrauterine device [IUD], double barrier method, male partner sterilization) before admission and throughout the study

Exclusion Criteria:

  • Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, cholelithiasis (gall stone disease), chronic idiopathic jaundice, family history of cholestatic jaundice, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • 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 clinically significant abnormal 12-lead ECG, vital signs, or physical examination at screening as deemed appropriate by the investigator
  • Participant has a history or presence of disorders commonly accepted as contraindications to sex hormonal therapy including, but not limited to, the following: a) Deep vein thrombophlebitis or thromboembolic disorders; b) Cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines; c) Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products; d) Known or suspected estrogen-dependent neoplasia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03274297

Contacts
Contact: Study contact 8444344210 JNJ.CT@sylogent.com
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email JNJ.CT@sylogent.com

Locations
Belgium
Clinical Pharmacology Unit Not yet recruiting
Merksem, Belgium, 2170
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03274297     History of Changes
Other Study ID Numbers: CR108360
2017-002186-22 ( EudraCT Number )
RWJ10553CON4001 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: September 5, 2017
Last Updated: September 5, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017