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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment sequence AB
Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay
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.
Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
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
Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay
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.
Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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