Norethisterone

Generic Name: Norethisterone

Brand Names: Activella 1/0.5 28 Day, Activelle, Alyacen 1/35, Alyacen 7/7/7, Amabelz 0.5/0.1 28 Day, Aranelle 28, Aurovela, Aurovela Fe, Aygestin, Balziva 28 Day, Blisovi 21 Fe 1.5/30 28 Day Pack, Blisovi 21 Fe 1/20 28 Day Pack, Blisovi 24 Fe 1/20 28 Day, Brevicon, Briellyn 28 Day, Camila 28 Day, Charlotte 24 Fe Chewable 28 Day, Combipatch, Cyclafem 1/35 28 Day, Cyclafem 7/7/7 28 Day, Cyonanz 28 Day, Dasetta 1/35 28 Day, Dasetta 7/7/7 28 Day, Deblitane 28 Day, Emzahh 28 Day, Errin 28 Day, Estalis, Etyqa 0.5/0.1 28 Day, Femcon Fe 28 Day, Femhrt 0.5/2.5 28 Day, Finzala 24 Fe Chewable 28 Day, Fyavolv, Gemmily 28 Day, Hailey 1.5/30 21 Day, Hailey 24 Fe 28 Day, Hailey Fe 1.5/30 28 Day, Hailey Fe 1/20 28 Day, Heather 28 Day, Incassia, Jencycla 28 Day, Jinteli, Junel 1.5/30 21 Day, Junel 1/20 21 Day, Junel Fe 1.5/30 28 Day, Junel Fe 1/20 28 Day, Junel Fe 24 1/20 28 Day, Kaitlib Fe 28 Day, Larin 1.5/30, Larin 1/20, Larin 24 Fe 1/20, Larin Fe 1.5/30, Larin Fe 1/20, Layolis Fe 28, Leena 28 Day, Lo Loestrin Fe 28 Day, Loestrin 1.5/30 21 Day, Loestrin 24 Fe 28 Day, Loestrin Fe 1/20 28 Day, Lolo, Lomedia 24 Fe, Lopreeza 1/0.5 28 Day, Lupaneta Pack 1-month, Lyleq 28 Day, Lyza, Melodetta 24 Fe Chewable 28 Day, Merzee 28 Day, Mibelas 24 Fe Chewable 28 Day, Microgestin 1.5/30 21 Day, Microgestin 1/20 21 Day, Microgestin 24 Fe 28 Day, Microgestin Fe 1.5/30 28 Day, Microgestin Fe 1/20 28 Day, Mimvey, Minastrin 24 Fe Chewable 28 Day, Myfembree, Necon 0.5/35 28 Day, Necon 1/35 28 Day, Necon 7/7/7 28 Day, Nexesta Fe 28 Day, Nora-BE 28 Day, Norlutate, Norlyda 28 Day, Norlyroc 28 Day, Nortrel 1/35 21 Day, Nortrel 1/35 28 Day, Nortrel 7/7/7 28 Day, Nylia 1/35 28 Day, Nylia 7/7/7 28 Day, Oriahnn 28 Day Kit, Ortho Micronor, Ortho Micronor 28 Day, Ortho-novum 7/7/7 28 Day, Philith 28 Day, Pirmella 1/35 28 Day, Pirmella 7/7/7 28 Day, Rhuzdah 28 Day, Select, Sharobel 28 Day, Synphasic, Tarina 24 Fe 1/20 28 Day, Tarina Fe 1/20 28 Day, Taysofy 28 Day, Taytulla 28 Day, Tilia Fe, Tri-legest 28 Day, Tulana 28 Day, Vyfemla 28 Day, Wera 28 Day, Wymzya Fe 28 Day, Zenchent

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₆O_₂

CAS Number: 68-22-4

Unique Ingredient Identifier: T18F433X4S

Background: Norethisterone, also known as norethindrone, is a synthetic progestational hormone belonging to the 19-nortestosterone-derived class of progestins. It is further classified as a second-generation progestin, along with levonorgestrel and its derivatives, and is the active form of several other progestins including norethynodrel and lynestrenol. Norethisterone mimics the actions of endogenous progesterone, albeit with a greater potency, and is used on its own or in combination with estrogen derivatives in a variety of applications including contraception and hormone replacement therapy. First derived in 1951 in Mexico City, norethisterone was originally intended for use as a remedy for irregular menstruation and endometriosis, and was not marketed for use as an oral contraceptive until 1962.

Indication: Norethisterone is indicated as an oral contraceptive when given as monotherapy or in combination with an estrogen component, such as ethinylestradiol or estradiol. In combination with an estrogen component, oral norethisterone is also indicated as a hormone replacement therapy in the treatment of postmenopausal osteoporosis and moderate-to-severe vasomotor symptoms arising from menopause. When applied via transdermal patch, the combination of norethisterone and estradiol is indicated for the treatment of hypoestrogenism, vulvovaginal atrophy, and moderate-severe vasomotor symptoms.

Norethisterone, taken in combination with intramuscular leuprolide, is also indicated for the symptomatic treatment of endometriosis-related pain.

Associated Conditions: Endometriosis related pain, Heavy Menstrual Bleeding, Moderate to Severe Vasomotor Symptoms, Osteoporosis, Postmenopausal Osteoporosis, Severe Pain, Vulvo Vaginal Atrophy, Hypoestrogenism, Moderate, severe, Vasomotor Symptoms caused by Menopause

Associated Therapies: Contraception, Hormone Replacement Therapy, Oral Contraceptives

Clinical Trials

Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

Not Applicable

Completed

Conditions: Endometrial Hyperplasia

Interventions: Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
Drug: Norethisterone Acetate tablets

First Posted Date: 2011-12-26

Last Posted Date: 2011-12-26

Lead Sponsor: Mansoura University

Target Recruit Count: 120

Registration Number: NCT01499602

Locations: 🇪🇬
Mansoura University Hospitals,OB/GYN department, Mansoura, Dakahlia Governorate, Egypt

Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

Phase 1

Completed

Conditions: Menopause
Healthy

Interventions: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

First Posted Date: 2011-11-22

Last Posted Date: 2016-01-15

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 24

Registration Number: NCT01477632

Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition

Phase 2

Conditions: Secondary-progressive Multiple Sclerosis
Primary-progressive Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis

Interventions: Other: Placebo
Drug: estriol
Other: Progestin Placebo
Drug: Norethindrone

First Posted Date: 2011-11-06

Last Posted Date: 2019-11-06

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 64

Registration Number: NCT01466114

Locations: 🇺🇸
The University of Colorado Denver, Aurora, Colorado, United States
🇺🇸
The University of New Mexico, Albuquerque, New Mexico, United States
🇺🇸
The University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 1 locations