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EVRA contraceptive patch NGMN and EE

Phase 1

Contraception | Small molecule | Endocrine |Johnson & Johnson|Trials 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

EVRA contraceptive patch NGMN and EE clinical trials

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)
ContraceptionUnlock trial analytics

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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Frequently asked questions about EVRA contraceptive patch NGMN and EE

What is EVRA contraceptive patch NGMN and EE?

EVRA is a transdermal contraceptive patch containing norelgestromin (NGMN) and ethinyl estradiol (EE). It is worn on the skin to deliver hormones for contraception. The patch is developed by Johnson & Johnson, which trades under the ticker JNJ, and it falls within the endocrine therapeutic area as a small molecule product.

What is EVRA contraceptive patch NGMN and EE used for?

EVRA contraceptive patch NGMN and EE is used for contraception in women. It delivers norelgestromin and ethinyl estradiol through the skin to prevent pregnancy. The clinical program recorded in public registries lists contraception and female contraception as the studied conditions, and enrolled participants were female adults aged 18 years and older.

Who makes EVRA contraceptive patch NGMN and EE?

Johnson & Johnson, ticker JNJ, is the developer of the EVRA contraceptive patch NGMN and EE. The company is listed as the sponsor behind the clinical development program for this transdermal contraceptive patch containing norelgestromin and ethinyl estradiol.

What phase is EVRA contraceptive patch NGMN and EE in?

EVRA contraceptive patch NGMN and EE is at the Phase 1 stage of clinical development based on the registered trial record. It is an investigational asset in this dataset rather than a marketed product, and the single registered study has completed. No active trials are currently listed for this patch.

What clinical trials is EVRA contraceptive patch NGMN and EE in?

One registered trial covers EVRA contraceptive patch NGMN and EE: NCT00258076, titled A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch). It was a Phase 1, randomized, uncontrolled study that completed with 53 enrolled female participants aged 18 years and older.