The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01535820
First received: February 15, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay
Drug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters of NGMN as measured by AUC, Cmax, tmax, and Css.

  • 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. ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters of EE as measured by AUC, Cmax, tmax, and Css.

  • Incidence of adverse events as a measure of safety and tolerability [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]
  • The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01535820

Locations
United States, New Jersey
Neptune, New Jersey, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01535820     History of Changes
Other Study ID Numbers: CR100412, NRGEEPCON1017
Study First Received: February 15, 2012
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Healthy volunteers
ORTHO EVRA
Contraceptive hormones
Transdermal patch
Progestin norelgestromin (NGMN)
Estrogen ethinyl estradiol (EE)
JNJ-93964
JNJ-622206

Additional relevant MeSH terms:
Hormones
Ethinyl Estradiol
Contraceptive Agents
Ortho Evra
Norgestrel
Norelgestromin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Estrogens
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 30, 2014