- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01535820
The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
March 19, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Bioequivalence Study to Evaluate the Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
The purpose of this study is to assess the bioequivalence of the contraceptive hormones of ORTHO EVRA when the patch is applied with and without an adhesive overlay.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), single-center, single-application, 2-way crossover study (participants receive different interventions sequentially during the trial) of ORTHO EVRA with and without an adhesive overlay.
ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl estradiol (EE).
The participants will be randomly assigned to 1 of 2 possible treatment sequences to ensure that they receive both of the following treatments, 1 in each period: - Treatment A: ORTHO EVRA patch applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system; - Treatment B: ORTHO EVRA patch applied to the buttock without an overlay.
The study consists of a screening phase; an open-label treatment phase consisting of 2 single-application 7-day treatment periods; and end-of-study or withdrawal assessments done upon completion of the 240-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal.
Pharmacokinetic evaluations explore how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time.
The two treatment periods will be separated by a washout period (period when receiving no treatment) of 21 days.
During the study, safety and tolerability will also be assessed.
The total duration of participation in the study for an individual will be approximately 2 months.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Neptune, New Jersey, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Signed informed consent
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg and not more than 90 kg
- Must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing an effective method of non-hormonal birth control (eg, non-hormonal intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study
- Completed her last term pregnancy at least 90 days before admission to the study site
- History of regular menstrual cycles (occurring every 25 to 35 days)
- Must not be pregnant or lactating
- Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic
- Hemoglobin equal or more than 12.0 at screening
Exclusion Criteria:
- History of smoking or use of nicotine-containing substances
- Used steroid hormonal therapy within 30 days before admission to the study
- Received a Depo Provera® injection in the 6 months before admission to the study
- History or presence of disorders commonly accepted as contraindications to sex hormonal therapy
- History of or current clinically significant medical illness or any other condition that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment sequence AB
|
NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use.
EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use.
A single patch is applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system for 7 days.
NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use.
EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use.
A single patch is applied to the buttock without an overlay for 7 days.
|
Experimental: Treatment sequence BA
|
NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use.
EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use.
A single patch is applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system for 7 days.
NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use.
EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use.
A single patch is applied to the buttock without an overlay for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NGMN plasma concentrations (Periods 1 and 2)
Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
EE plasma concentrations (Periods 1 and 2)
Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters of NGMN (Periods 1 and 2)
Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
Pharmacokinetic parameters of NGMN as measured by AUC, Cmax, tmax, and Css.
|
At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
Pharmacokinetic parameters of EE (Periods 1 and 2)
Time Frame: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
Pharmacokinetic parameters of EE as measured by AUC, Cmax, tmax, and Css.
|
At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
|
Incidence of adverse events as a measure of safety and tolerability
Time Frame: Approximately 2 months
|
Approximately 2 months
|
|
The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements
Time Frame: Approximately 2 months
|
Approximately 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 15, 2012
First Submitted That Met QC Criteria
February 15, 2012
First Posted (Estimate)
February 20, 2012
Study Record Updates
Last Update Posted (Estimate)
March 20, 2013
Last Update Submitted That Met QC Criteria
March 19, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100412
- NRGEEPCON1017 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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