Healthy Volunteers
Conditions
Keywords
Healthy volunteers, ORTHO EVRA, Contraceptive hormones, Transdermal patch, Progestin norelgestromin (NGMN), Estrogen ethinyl estradiol (EE), JNJ-93964, JNJ-622206
Brief 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.
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.
Interventions
DRUGTreatment 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.
DRUGTreatment 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.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NGMN plasma concentrations (Periods 1 and 2) | At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. |
| EE plasma concentrations (Periods 1 and 2) | At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of NGMN (Periods 1 and 2) | 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. |
| Pharmacokinetic parameters of EE (Periods 1 and 2) | 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. |
| Incidence of adverse events as a measure of safety and tolerability | Approximately 2 months | — |
| The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements | Approximately 2 months | — |
Countries
United States
Outcome results
None listed