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Norelgestromin

Generic Name: Norelgestromin

Brand Names: Evra, Xulane, Zafemy

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₉NO_₂

CAS Number: 53016-31-2

Unique Ingredient Identifier: R0TAY3X631

Overview

Norelgestromin is a drug used in contraception. Norelgestromin is the active progestin responsible for the progestational activity that occurs in women after application of ORTHO EVRA patch.

Background

Norelgestromin is a drug used in contraception. Norelgestromin is the active progestin responsible for the progestational activity that occurs in women after application of ORTHO EVRA patch.

Indication

Norelgestromin is used for contraception and menopausal hormonal therapy. Norelgestromin may potentially be used in breast cancer treatment due to its inhibitory effect on estrone sulfatase . They convert sulfated steroid precursors to estrogen during pregnancy.

Associated Conditions

Polycystic Ovarian Syndrome (PCOS)

Clinical Trials

A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women

Phase 1

Completed

Posted: 2019/07/12

Sponsor:Janssen Research & D...

ID:NCT04017195

A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women

Phase 4

Completed

Posted: 2017/09/06

Sponsor:Janssen Research & D...

ID:NCT03274297

Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity

Phase 2

Posted: 2007/02/26

Sponsor:University of Washin...

ID:NCT00439972

Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.

Phase 4

Completed

Posted: 2005/12/05

Sponsor:

Janssen Pharmaceutic...

ID:NCT00261482

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)

Phase 1

Completed

Posted: 2005/11/24

Sponsor:Johnson & Johnson Ph...

ID:NCT00258063

FDA Approved Products

Norelgestromin and Ethinly Estradiol

Manufacturer:Amneal Pharmaceuticals NY LLC

Route:TRANSDERMAL

Strength:150 ug in 1 d

Approved: 2023/12/30

NDC:69238-1521

ZAFEMY

Manufacturer:AvKARE

Route:TRANSDERMAL

Strength:150 ug in 1 d

Approved: 2023/05/15

NDC:42291-930

XULANE

Manufacturer:Mylan Pharmaceuticals Inc.

Route:TRANSDERMAL

Strength:150 ug in 1 d

Approved: 2021/02/04

NDC:0378-3340

ZAFEMY

Manufacturer:Amneal Pharmaceuticals LLC

Route:TRANSDERMAL

Strength:150 ug in 1 d

Approved: 2023/05/01

NDC:65162-358

norelgestromin and ethinyl estradiol

Manufacturer:Zydus Pharmaceuticals USA Inc.

Route:TRANSDERMAL

Strength:150 ug in 1 mg

Approved: 2023/09/16

NDC:70710-1190

Singapore Approved Products

EVRA TRANSDERMAL PATCH (6 mg/600 mcg)

Manufacturer:LTS LOHMANN THERAPIE-SYSTEME AG

Form:PATCH

Strength:6 mg/patch

Online:Yes

Approved: 2003/09/17

Approval:SIN12423P

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