NCT01535820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

February 15, 2012

Last Update Submit

March 19, 2013

Conditions

Healthy Volunteers

Keywords

Healthy volunteersORTHO EVRAContraceptive hormonesTransdermal patchProgestin norelgestromin (NGMN)Estrogen ethinyl estradiol (EE)JNJ-93964JNJ-622206

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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 EE (Periods 1 and 2)

    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

    Approximately 2 months

  • The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements

    Approximately 2 months

Study Arms (2)

Treatment sequence AB

EXPERIMENTAL
Drug: Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlayDrug: 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 overlayDrug: Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay

Interventions

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 sequence ABTreatment sequence BA
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.

Treatment sequence ABTreatment sequence BA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neptune City, New Jersey, United States

Location

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 20, 2012

Study Start

March 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

US(1)