Healthy VolunteersPhase 1NCT01535820
The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
A Phase 1 study testing Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay and Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay in people with Healthy Volunteers, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay and Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay, Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
- Keywords
- Healthy volunteers, ORTHO EVRA, Contraceptive hormones, Transdermal patch, Progestin norelgestromin (NGMN), Estrogen ethinyl estradiol (EE), JNJ-93964, JNJ-622206
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlayDrug
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.
Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlayDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence AB | Experimental | Not described Receives: Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay; Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay |
| Treatment sequence BA | Experimental | Not described Receives: Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay; Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGMN plasma concentrations (Periods 1 and 2)
Measured: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
EE plasma concentrations (Periods 1 and 2)
Measured: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
Secondary outcomes (4)
Pharmacokinetic parameters of NGMN (Periods 1 and 2)
Pharmacokinetic parameters of NGMN as measured by AUC, Cmax, tmax, and Css.
Measured: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
Pharmacokinetic parameters of EE (Periods 1 and 2)
Pharmacokinetic parameters of EE as measured by AUC, Cmax, tmax, and Css.
Measured: 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
Measured: Approximately 2 months
The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535820
- Sponsor's protocol ID
- CR100412
- Other IDs
- NRGEEPCON1017
- Status last verified
- Mar 2013
- First submitted
- 15 Feb 2012
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study to Evaluate the Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
- ClinicalTrials.gov ID
- NCT01535820
- Acronym / sponsor ID
- CR100412
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, ORTHO EVRA, Contraceptive hormones, Transdermal patch, Progestin norelgestromin (NGMN), Estrogen ethinyl estradiol (EE), JNJ-93964, JNJ-622206
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence AB | Experimental | Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay, Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay |
| Treatment sequence BA | Experimental | Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay, Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlayNGMN: 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 sequence AB, Treatment sequence BA |
| Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlayNGMN: 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. | Drug | Treatment sequence AB, Treatment sequence BA |
Primary outcome
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.
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.
4 secondary outcomes
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 EE (Periods 1 and 2)
Time frame: 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
The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements
Time frame: Approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay and Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay in people with Healthy Volunteers, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.