MedTrace Logo

A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers

NCT00254865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-06-08

No results posted yet for this study

Summary

The objective of this study is to compare the levels of the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers administered ORTHO EVRA® (a transdermal contraceptive patch) and CILEST® (an oral contraceptive). The open-label treatment phase of the study consists of two 28-day cycles of one treatment, a washout period of 28 days, and crossover to two 28-day cycles of the other treatment.

Conditions

  • Contraception
  • Female Contraception

Interventions

DRUG

EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.75 mg of ethinyl estradiol (versus CILEST® tablets).

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-08-31
Completion
2003-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00254865 on ClinicalTrials.gov