WO2014080282A3 - One- and two-point titration methods to determine daily treatment regimens to treat hypogonadism or testosterone deficiency - Google Patents

One- and two-point titration methods to determine daily treatment regimens to treat hypogonadism or testosterone deficiency Download PDF

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Publication number
WO2014080282A3
WO2014080282A3 PCT/IB2013/002920 IB2013002920W WO2014080282A3 WO 2014080282 A3 WO2014080282 A3 WO 2014080282A3 IB 2013002920 W IB2013002920 W IB 2013002920W WO 2014080282 A3 WO2014080282 A3 WO 2014080282A3
Authority
WO
WIPO (PCT)
Prior art keywords
testosterone
male
present
hypogonadism
relates
Prior art date
Application number
PCT/IB2013/002920
Other languages
French (fr)
Other versions
WO2014080282A2 (en
Inventor
Paul Jose Pierre Marie Maes
Wayne KREPPNER
Jodi Beth DICKSTEIN
Natalia TKACHENKO
Original Assignee
Trimel Biopharma Srl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Trimel Biopharma Srl filed Critical Trimel Biopharma Srl
Publication of WO2014080282A2 publication Critical patent/WO2014080282A2/en
Publication of WO2014080282A3 publication Critical patent/WO2014080282A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens

Abstract

The present invention relates to 4.0% and 4.5 % intranasal testosterone bioadhesive gels for providing sustained intranasal delivery of testosterone to a male and intranasal treatment methods for safely providing sustained release testosterone to treat males with hypogonadism. The present invention also relates to a system for dispensing intranasally a precise dosage amount of such gels in smaller volumes at an optimal anatomical location within each nostril of the male, so that an effective amount of testosterone is deposited within each nostril at the optimal anatomical location for TRT, including to effectively treat testosterone deficiency in male subjects, such as hypogonadism. The present invention is also concerned with a novel titration method to determine the appropriate daily treatment regimen, i.e., a BID or TIO treatment regimen. Further, the present invention relates to a novel method of preventing the occurrence of an allergic rhinitis event in a male.
PCT/IB2013/002920 2012-11-22 2013-11-22 One-and two-point titration methods to determine daily treatment regimens to treat hypogonadism or male testosterone deficiency with an intranasal testosterone bio-adhesive gel, and primary and secondary efficacy and safety endpoints WO2014080282A2 (en)

Applications Claiming Priority (16)

Application Number Priority Date Filing Date Title
US201261729406P 2012-11-22 2012-11-22
US61/729,406 2012-11-22
US201361802354P 2013-03-15 2013-03-15
US201361802297P 2013-03-15 2013-03-15
US61/802,354 2013-03-15
US61/802,297 2013-03-15
US201361802388P 2013-03-16 2013-03-16
US61/802,388 2013-03-16
US201361802737P 2013-03-17 2013-03-17
US201361802727P 2013-03-17 2013-03-17
US201361802739P 2013-03-17 2013-03-17
US201361802724P 2013-03-17 2013-03-17
US61/802,727 2013-03-17
US61/802,739 2013-03-17
US61/802,737 2013-03-17
US61/802,724 2013-03-17

Publications (2)

Publication Number Publication Date
WO2014080282A2 WO2014080282A2 (en) 2014-05-30
WO2014080282A3 true WO2014080282A3 (en) 2014-11-06

Family

ID=50776620

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2013/002920 WO2014080282A2 (en) 2012-11-22 2013-11-22 One-and two-point titration methods to determine daily treatment regimens to treat hypogonadism or male testosterone deficiency with an intranasal testosterone bio-adhesive gel, and primary and secondary efficacy and safety endpoints

Country Status (1)

Country Link
WO (1) WO2014080282A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8492369B2 (en) 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
EP2985026B1 (en) 2005-04-15 2022-08-03 Clarus Therapeutics, Inc. Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
WO2019175290A1 (en) 2018-03-13 2019-09-19 Beckley Canopy Therapeutics Limited Cannabis or cannabis derived compositions for promoting cessation of chemical dependence
WO2020132163A1 (en) * 2018-12-20 2020-06-25 Clarus Therapeutics, Inc. Methods of treating testosterone deficiency

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060211664A1 (en) * 2002-10-18 2006-09-21 Dudley Robert E Method for treating erectile dysfunction and increasing libido in men
US20090299156A1 (en) * 2008-02-20 2009-12-03 Dexcom, Inc. Continuous medicament sensor system for in vivo use

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060211664A1 (en) * 2002-10-18 2006-09-21 Dudley Robert E Method for treating erectile dysfunction and increasing libido in men
US20090299156A1 (en) * 2008-02-20 2009-12-03 Dexcom, Inc. Continuous medicament sensor system for in vivo use

Also Published As

Publication number Publication date
WO2014080282A2 (en) 2014-05-30

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