Methyltestosterone

Overview

A synthetic anabolic steroid used for treating men with testosterone deficiency or similar androgen replacement therapies. Also, has antineoplastic properties and so has been used secondarily in women with advanced breast cancer. Methyltestosterone is a schedule III drug in the US.

Indication

Methyltestosterone is an anabolic steroid hormone used to treat men with a testosterone deficiency. It is also used in women to treat breast cancer, breast pain, swelling due to pregnancy, and with the addition of estrogen it can treat symptoms of menopause.

Associated Conditions

Hypergonadotropic Hypogonadism
Idiopathic Hypogonadotropic Hypogonadism
Metastatic Breast Cancer
Puberty, Delayed
Testosterone Deficiency

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes	2005/09/12	NCT00160342	Phase 2	Completed	Solvay Pharmaceuticals
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women	2005/09/01	NCT00141557	Phase 2	Terminated	Solvay Pharmaceuticals
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women	2005/09/01	NCT00141544	Phase 2	Terminated	Solvay Pharmaceuticals
Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women	2005/09/01	NCT00141570	Phase 2	Completed	Solvay Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
METHITEST	Amneal Pharmaceuticals of New York LLC	0115-7037	ORAL	10 mg in 1 1	5/28/2019
Methyltestosterone	Novitium Pharma LLC	70954-255	ORAL	10 mg in 1 1	2/22/2022
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE	Syntho Pharmaceuticals, Inc.	66576-284	ORAL	2.5 mg in 1 1	12/7/2022
Esterified Estrogens and Methyltestosterone	ANI Pharmaceuticals, Inc.	62559-149	ORAL	2.5 mg in 1 1	12/1/2017
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE	Syntho Pharmaceuticals, Inc.	66576-283	ORAL	1.25 mg in 1 1	12/7/2022
Esterified Estrogens and Methyltestosterone	Bryant Ranch Prepack	63629-1979	ORAL	2.5 mg in 1 1	12/1/2017
COVARYX	CENTRIX PHARMACEUTICAL, INC,	11528-010	ORAL	2.5 mg in 1 1	1/25/2020
Esterified Estrogens and Methyltestosterone	Amneal Pharmaceuticals of New York LLC	53746-078	ORAL	2.5 mg in 1 1	12/31/2023
Esterified Estrogens and Methyltestosterone	Bryant Ranch Prepack	72162-1748	ORAL	1.25 mg in 1 1	8/29/2023
COVARYX HS	CENTRIX PHARMACEUTICAL, INC,	11528-020	ORAL	1.25 mg in 1 1	1/25/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
METHYLTESTOSTERONE CAP 25MG	N/A	Swiss Pharmaceutical (HK) Company Limited	N/A	N/A	4/28/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
METANDREN 25MG	novartis pharmaceuticals canada inc	00005630	Tablet - Oral	25 MG / TAB	12/31/1992
METANDREN 10MG	novartis pharmaceuticals canada inc	00005622	Tablet - Oral	10 MG / TAB	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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