Page last updated: 2024-11-13

ortho evra

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

Ortho Evra: a combination transdermal contraceptive patch with a contact surface area of 20 cm2. It contains 6 mg norelgestromin and 0.75 mg ethinyl estradiol; was indexed to norelgestromin (2002-2006) [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID53461729
MeSH IDM0492373

Synonyms (2)

Synonym
ortho evra
FT-0665916

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"Treatment-emergent adverse events of 2% or greater in the LNG/EE contraceptive patch were nasopharyngitis (5."( Safety and tolerability of a new low-dose contraceptive patch in obese and nonobese women.
Archer, DF; Foegh, M; Kaunitz, AM; Mishell, DR, 2015
)
0.42
"The LNG/EE contraceptive patch and combination oral contraceptives were well tolerated and associated with similar treatment-emergent adverse event incidences in obese and nonobese women."( Safety and tolerability of a new low-dose contraceptive patch in obese and nonobese women.
Archer, DF; Foegh, M; Kaunitz, AM; Mishell, DR, 2015
)
0.42

Pharmacokinetics

ExcerptReferenceRelevance
" The method has been successfully applied to a pharmacokinetic study of the ORTHO EVRA patch in rabbits."( Determination of norelgestromin in rabbit plasma by LC-MS/MS and its application to the pharmacokinetic study of ORTHO EVRA.
Ding, C; Ge, Q; Liu, X; Zhi, X; Zhou, Z, 2009
)
0.35

Dosage Studied

ExcerptRelevanceReference
"Film forming polymeric solutions may present an alternative to the common transdermal dosage forms such as patches or gels."( Delivery of ethinylestradiol from film forming polymeric solutions across human epidermis in vitro and in vivo in pigs.
Franke, P; Lehr, CM; Schaefer, UF; Zurdo Schroeder, I, 2007
)
0.34
" This might be an effect of the convenience of the weekly dosing schedule."( Evaluation of the contraceptive efficacy, compliance, and satisfaction with the transdermal contraceptive patch system Evra: a comparison between adolescent and adult users.
Bodner, K; Bodner-Adler, B; Grünberger, W, 2011
)
0.37
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (36)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's12 (33.33)29.6817
2010's20 (55.56)24.3611
2020's4 (11.11)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials9 (23.68%)5.53%
Reviews3 (7.89%)6.00%
Case Studies2 (5.26%)4.05%
Observational0 (0.00%)0.25%
Other24 (63.16%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (8)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Bioequivalence Study to Evaluate the Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women [NCT01535820]Phase 154 participants (Actual)Interventional2011-03-31Completed
The Effects of Oral Contraceptive Pills vs Hormonal Patch on Coagulation Parameters [NCT00554632]24 participants (Actual)Interventional2003-04-30Completed
An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra [NCT00269620]Phase 4500 participants (Actual)Interventional2005-06-30Completed
Comparison of Oral and Patch Forms of Hormonal Contraception on Plasma Lipoproteins, Glycemia, Clotting Factors, Indices of Inflammation and Vascular Reactivity [NCT00439972]Phase 236 participants (Anticipated)Interventional2007-02-28Active, not recruiting
A Phase II Pharmacokinetic Study of the Transdermal Contraceptive System and Oral Contraceptive in HIV-1 Infected Women on Lopinavir/Ritonavir [NCT00125983]Phase 232 participants (Actual)InterventionalCompleted
Postmarketing Study of ORTHO EVRA in Relation to Venous Thromboembolism, Ischemic Stroke, and Myocardial Infarction [NCT00331071]334 participants (Actual)Observational2002-04-30Completed
Patient Experiences Using Evra for Management of Menstrual Related Symptoms. [NCT00357981]0 participants (Actual)InterventionalWithdrawn(stopped due to Both sponsor and UCSF decided this study was not clinical relevant at this time)
The Pharmacokinetics of 12 Week Continuous Patch Use [NCT02585999]30 participants (Actual)Interventional2015-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT02585999 (2) [back to overview]Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
NCT02585999 (2) [back to overview]NGMN Levels Over 12 Weeks of Continuous Patch Use

Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use

Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2 (NCT02585999)
Timeframe: Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removed

Interventionpg/ml (Mean)
Week 1 (end)Week 2 (end)Week 3 (end)Week 3.5 (mid-week)Week 4 (end)Week 5 (end)Week 6 (end)Week 7 (end)Week 7.5 (mid-week)Week 8 (end)Week 9 (end)Week 10 (end)Week 11 (end)Week 11.5 (mid-week)Week 12 (end)Week 12.1 (day 1 post patch)Week 12.2 (day 2 post patch)Week 12.3 (day 3 post patch)
Xulane12.514.310.942.925.934.136.724.74832.840.742.641.247.12717.81210.4

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NGMN Levels Over 12 Weeks of Continuous Patch Use

Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN (NCT02585999)
Timeframe: 12 weeks

Interventionng/ml (Mean)
Week 1 (end)Week 2 (end)Week 3 (end)Week 3.5 (mid-week)Week 4 (end)Week 5 (end)Week 6 (end)Week 7 (end)Week 7.5 (mid-week)Week 8 (end)Week 9 (end)Week 10 (end)Week 11 (end)Week 11.5 (mid-week)Week 12 (end)Week 12.1 (day 1 post patch)Week 12.2 (day 2 post patch)Week 12.3 (day 3 post patch)
Xulane0.6910.6990.6741.090.7460.8770.9130.6891.060.7890.8140.8370.7920.9540.5930.4220.2210.163

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