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EVRA contraceptive patch NGMN and EE

Phase 1

Contraception | Small molecule | Endocrine |Johnson & Johnson|Last Updated: Dec 12, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

EVRA contraceptive patch NGMN and EE · 1 trial · 2 indications

Phase 1 1
NCT00258076A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)Contraception
COMPLETED53 Analytics
PHASE1COMPLETED
A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)
Contraception
NCT0025807653
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Study Endpoints

Primary Endpoints

A comparison of the exposure and pharmacokinetics of NGMN, NG, and EE after a single patch application of different commercial lots of ORTHO EVRA and a comparison of these data to historical hormonal data from a clinical development patch.

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).
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALEVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EE

Interventions

NameTypeDescription
EVRA transdermal contraceptive patch 6 mg NGMN and 0.75 mg EEDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersNo

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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