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EVRA contraceptive patch containing of norelgestromin and of ethinyl estradiol

Phase 1

Contraception | Small molecule | Endocrine |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

EVRA contraceptive patch containing of norelgestromin and of ethinyl estradiol · 2 trials · 2 indications

Phase 1 2
NCT00258063A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)Contraception
COMPLETED60 Analytics
NCT00254865A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female VolunteersContraception
COMPLETED34 Analytics
PHASE1COMPLETED
A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)
Contraception
NCT0025806360
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PHASE1COMPLETED
A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers
Contraception
NCT0025486534
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Study Endpoints

Primary Endpoints

A comparison of exposure and pharmacokinetics for norelgestromin, (NGMN), norgestrel (NG), and ethinyl estradiol (EE) for EVRA®, CILEST® and historical data from one ORTHO EVRA® clinical development lot.
A comparison of the total exposure and pharmacokinetics, over comparable time intervals (Week 1 of Cycle 1 and Week 3 of Cycle 2), of NGMN, NG, and EE for ORTHO EVRA® and CILEST®.

Secondary Endpoints

An assessment of safety from screening to final visit (incidence of adverse events, changes in physical, gynecologic and breast examinations, vital signs, laboratory tests and electrocardiogram results).
Pharmacodynamic measurements [sex hormone-binding globulin (SHBG), corticosteroid binding globulin (CBG), and corticosteroid-binding globulin binding capacity (CBG-BC)] during pre-treatment, Cycle 1, Washout and Cycle 2.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.60 mg of ethinyl estradiol (versus CILEST® tablets).DRUG -
EVRA® transdermal contraceptive patch containing 6 mg of norelgestromin and 0.75 mg of ethinyl estradiol (versus CILEST® tablets).DRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Subjects who are not pregnant (as demonstrated by negative pregnancy tests at screening and before admission for each treatment period) and who have completed their last term pregnancy at least 60 days before the admission visit * confirmed to be in good health as determined b...

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