WO1995013072A1 - The use of alfuzosin or terazosin in the treatment of premature ejaculation - Google Patents

The use of alfuzosin or terazosin in the treatment of premature ejaculation Download PDF

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Publication number
WO1995013072A1
WO1995013072A1 PCT/EP1994/003661 EP9403661W WO9513072A1 WO 1995013072 A1 WO1995013072 A1 WO 1995013072A1 EP 9403661 W EP9403661 W EP 9403661W WO 9513072 A1 WO9513072 A1 WO 9513072A1
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WO
WIPO (PCT)
Prior art keywords
treatment
terazosine
alfuzosine
premature ejaculation
patients
Prior art date
Application number
PCT/EP1994/003661
Other languages
French (fr)
Inventor
Giorgio Cavallini
Original Assignee
Giorgio Cavallini
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 Giorgio Cavallini filed Critical Giorgio Cavallini
Priority to US08/624,603 priority Critical patent/US5707999A/en
Priority to JP7513583A priority patent/JPH09504798A/en
Priority to EP94931582A priority patent/EP0728000A1/en
Publication of WO1995013072A1 publication Critical patent/WO1995013072A1/en

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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to the use of ⁇ l blockers in the treatment of premature ejaculation.
  • the treatment of choice is psychotherapy, either as a behavioural dual team sex therapy according to Master & Johnson protocol, or individual psychotherapy (Rifelli and Moro. Sessuologia Clinica. Bologna, 1989).
  • Ejaculation is a centrally integrated peripheral evoked reflex, which occurs thanks to an ⁇ l adrenergic receptor activation.
  • alfuzosine and terazosine and the pharmaceutically acceptable salts thereof for the preparation of a medicament useful for the treatment of psychogenic premature ejaculation.
  • Alfuzosine and terazosine are ⁇ l blockers used in j ⁇ the treatment of hypertension or in the symptomatic treatment of benign prostatic hyperplasia.
  • Criteria for the participation in the study were absence of: uncontrolled hypertension, orthostatic hypotension, thyroid- diseases..,, uncontrolled diabetes, recent miocardial infarction, use of alfuzosine or of terazosine in the previous 4 months, sexual life characterised by occasional intercourses. . - ⁇ ()
  • the patients were randomized in three groups: two of 36 and one of 35 patients. Each group used alfuzosine, terazosine or placebo in a different order.
  • the first group used the drugs as follows: alfuzosine, terazosine, placebo; the second group used first terazosine, followed by placebo and alfuzosine; the third group used first placebo, then alfuzosine and finally terazosine. Each drug was used during two months.
  • Alfuzosine dosage was 2x3 mg/day, terazosine 5 mg/day once a day (the dosage was gradually reached starting from 1 mg/day) and vitamin C 500x2 mg/day. in six patients dropped out from the study for unknown causes, and 4 patients had to be discharged from the study due to the side effects of the drugs.
  • Table 2 shows side-effects. The 4 patients who had been discharged from the clinical evaluation were also considered. ,0 Table 2
  • the dosage will be determined by the physician depending on the severity of the pathology and the general conditions of the patient.
  • dosages from 1 to 8 mg/day for alfuzosine and from 3 to 15 mg/day for terazosine can be envisaged", possibly subdivided into more- daily doses.
  • alfuzosine and terazosine can also be used in combination in the same medicament, or in combination with one or more compounds effective in the treatment of premature ' ejaculation, such as antiandrogens, metoclopramide, clomipramine, phenoxybenzamine, prazosine and lorazepam.
  • the preferred administration route is the oral one, but other administration routes can also be envisaged.
  • the drugs herein described will be administered in form of pharmaceutical compositions which can be prepared 10 according to conventional procedures, for example as described in Remington's Pharmaceutical Sciences Handbook, XVII ed, Mack, Pub., USA.
  • compositions are tablets, capsules sugar-coated pills, syrups, chewable J ⁇ formulations; suppositories and injectable formulations (intravenous, subcutaneous, intramuscular).

Abstract

The use of the a1-blockers drugs, alfuzosin and terazosin in the treatment of premature ejaculation is disclosed.

Description

THE USE OF ALFUZOSIN IN THE TREATMENT OF PREMATURE EJACULATION
The present invention relates to the use of αl blockers in the treatment of premature ejaculation.
Primitive psychogenic premature ejaculation is regarded as the most common sexual disorder of the male.
At present, the treatment of choice is psychotherapy, either as a behavioural dual team sex therapy according to Master & Johnson protocol, or individual psychotherapy (Rifelli and Moro. Sessuologia Clinica. Bologna, 1989). The first proved to be active in about 80% of the cases, and it needs an active couple with a strong background of conjugal life free from conflictualities, while the second proved to be active in 40%-60% of the cases (1). This means that a large amount of males do not benefit from the psychotherapy and still suffer from premature ejaculation.
Ejaculation is a centrally integrated peripheral evoked reflex, which occurs thanks to an αl adrenergic receptor activation.
Effective pharmacological drugs for the treatment of premature ejaculation exist, but they suffer from severe side effects, for example clomipramine and phenoxybenzamine . Other treatments have a limited effectiveness (metoclopramide and the like).
Now it has been found that two specific αl blockers, alfuzosine and terazosine, are effective in the treatment of psychogenic premature ejaculation. Particularly, said drugs turned out to be effective in patients who proved to have no benefit from psychological therapy.
Therefore, it is an object of the present invention the use of alfuzosine and terazosine and the pharmaceutically acceptable salts thereof for the preparation of a medicament useful for the treatment of psychogenic premature ejaculation.
Alfuzosine and terazosine are αl blockers used in jυ the treatment of hypertension or in the symptomatic treatment of benign prostatic hyperplasia. Up to now no paper can be found in literature about any possible use thereof in the treatment of psychogenic premature ejaculation, particularly in patients resistant to I.-.-- psychotherapy.
In the following, the clinical evaluation of alfuzosine and terazosine is illustrated.
107 Patients complaining psychogenic premature ejaculation were tested during 2 years. Age range was V'J 21-63 years, mean age 34.3 years: all of them were put into a blind cross-over prospective controlled trial.
Alfuzosine, terazosine and placebo (vitamin C) were used.
Criteria for the participation in the study were absence of: uncontrolled hypertension, orthostatic hypotension, thyroid- diseases..,, uncontrolled diabetes, recent miocardial infarction, use of alfuzosine or of terazosine in the previous 4 months, sexual life characterised by occasional intercourses. . -■() The patients were randomized in three groups: two of 36 and one of 35 patients. Each group used alfuzosine, terazosine or placebo in a different order. The first group used the drugs as follows: alfuzosine, terazosine, placebo; the second group used first terazosine, followed by placebo and alfuzosine; the third group used first placebo, then alfuzosine and finally terazosine. Each drug was used during two months. Alfuzosine dosage was 2x3 mg/day, terazosine 5 mg/day once a day (the dosage was gradually reached starting from 1 mg/day) and vitamin C 500x2 mg/day. in six patients dropped out from the study for unknown causes, and 4 patients had to be discharged from the study due to the side effects of the drugs.
At the end of each two-month period of treatment, the patients and their partners were separately asked ιr> wether or not they were satisfacted by the activity of the drugs: i.e. wether or not time required to reach ejaculation had been prolonged enough to be satisfactory for both. In 6 cases a disagreement about the times of orgasmic latency was evidenced between so patients and their partners and therefore these were discharged from the study.
At the end of the study, 91 cases were evaluated, which were subdivided into a first group of 30 patients, a second of 30 and a third of 31. Results were categorized as follows: positive (satisfactory for both partners.) or negative (unsatisfactory for both, partners). Data were analyzed with the chi square test. The results are listed in the following tables. Table 1 shows the activity of the drugs:
-J" alfuzosine proved to be active in 42 patients (46.2%), terazosine in 48 (53,7%) and placebo in 22 (24,2%). Table 1
Effect of αl-blockers in the treatment of premature ejaculation psychogenic
I group alfuzosine terazosine placebo positive results 14 (46.7%) 16 (53.3%) 8 (26.7%) negative results 16 (53.3%) 14 (46.7%) 22 (73.3%) TOTAL 30 30 30
II group terazosine placebo alfuzosine positive results 15 (50.0%) 10 (33.3%) 13 (43.3%) o negative results 15 (50.0%) 20 (66.7%) 17 (56.7%) TOTAL 30 30 30
III group placebo alfuzosine terazosine positive results 4 (12.9%) 16 (51.6%) 17 (54.8%) negative results 27 (87.1%) 15 (48.4%) 14 (45.2%) TOTAL 31 31 31
The results prove that alfuzosine and terazosine are significantly more active than placebo (chi square 8.70, p<0.05 and 14.50, p<0.01 respectively) whereas non significant differences were evidenced between 0 alfuzosine and terazosine (chi square 0.55, p not significant). When placebo was used as first (III group), this turned out to be active for 12.9% of cases,; on the other hand, when used after the α- blocker, it proved effective in about 30% of cases, a trend which, even though suggestive, is not significant (chi square 2.55).
Table 2 shows side-effects. The 4 patients who had been discharged from the clinical evaluation were also considered. ,0 Table 2
Side effects induced by the treatment with alfuzosine, terazosine and placebo.
Appearance of No side effects side effects
Alfuzosine 5~ (5.2%) 90 (94.8%)
Terazosine 3* (3.2%) 90 (96.7%)
Placebo 1+ (1.1%) 90 (98.9%)
3 patients reported hypotension (2 patients of group 1 interrupted the treatment and received no terazosine), 1 hypotension and epigastralgia, 1 epigastralgia.
* 2 patients of group 2 reported hypotension, interrupted the treatment and received no placebo, 1 reported headache.
+ 1 patient reported slight epigastralgia.
The results of clinical evaluation prove that αl- blockers alfuzosine and terazosine are effective in the treatment of psychogenic premature ejaculation, particularly in patients resistant to psychotherapy. The use of said drugs proved to be safe from the side effects point of view.
The dosage will be determined by the physician depending on the severity of the pathology and the general conditions of the patient.
Generally, dosages from 1 to 8 mg/day for alfuzosine and from 3 to 15 mg/day for terazosine can be envisaged", possibly subdivided into more- daily doses.
According to another object of the invention, alfuzosine and terazosine can also be used in combination in the same medicament, or in combination with one or more compounds effective in the treatment of premature ' ejaculation, such as antiandrogens, metoclopramide, clomipramine, phenoxybenzamine, prazosine and lorazepam.
The preferred administration route is the oral one, but other administration routes can also be envisaged.
According to the invention, the drugs herein described will be administered in form of pharmaceutical compositions which can be prepared 10 according to conventional procedures, for example as described in Remington's Pharmaceutical Sciences Handbook, XVII ed, Mack, Pub., USA.
Examples of pharmaceutical compositions are tablets, capsules sugar-coated pills, syrups, chewable J ^ formulations; suppositories and injectable formulations (intravenous, subcutaneous, intramuscular).

Claims

1. The use of alfuzosine and the pharmaceutically acceptable salts thereof for the preparation of a medicament for the treatment of psychogenic premature ejaculation.
2. The use of terazosine and the pharmaceutically acceptable salts thereof for the preparation of a medicament for the treatment of psychogenic premature
10 ejaculation.
3. The use of alfuzosine and the pharmaceutically acceptable salts thereof in combination with one or more compounds selected from antiandrogens, metoclopramide, clomipramine, phenoxybenzamine,
J 5 prazosine and lorazepam for the preparation of a medicament for the treatment of psychogenic premature ejaculation.
4. The use of terazosine and the pharmaceutically acceptable salts thereof in combination with one or
2d more compounds selected from antiandrogens, metoclopramide, clomipramine, phenoxybenzamine, prazosine and lorazepam for the preparation of a medicament for the treatment of psychogenic premature ejaculation.
PCT/EP1994/003661 1993-11-12 1994-11-08 The use of alfuzosin or terazosin in the treatment of premature ejaculation WO1995013072A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US08/624,603 US5707999A (en) 1993-11-12 1994-11-08 Use of alfuzosin or terazosin in the treatment of premature ejaculation
JP7513583A JPH09504798A (en) 1993-11-12 1994-11-08 Use of alfuzosin or terazosin in the treatment of premature ejaculation
EP94931582A EP0728000A1 (en) 1993-11-12 1994-11-08 The use of alfuzosin or terazosin in the treatment of premature ejaculation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI93A002412 1993-11-12
IT93MI002412A IT1264965B1 (en) 1993-11-12 1993-11-12 USE OF ALFA 1-BLOCCANTI IN THE TREATMENT OF EARLY EJACULATION

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WO1995013072A1 true WO1995013072A1 (en) 1995-05-18

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US (1) US5707999A (en)
EP (1) EP0728000A1 (en)
JP (1) JPH09504798A (en)
IT (1) IT1264965B1 (en)
WO (1) WO1995013072A1 (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5922341A (en) * 1997-10-28 1999-07-13 Vivus, Incorporated Local administration of pharmacologically active agents to treat premature ejaculation
US6037360A (en) * 1997-10-28 2000-03-14 Vivus, Incorporated Administration of 5-HT3 receptor antagonists to treat premature ejaculation
US6228864B1 (en) 1997-10-28 2001-05-08 Vivus, Inc. Administration of 5-HT receptor agonists and antagonists, to treat premature ejaculation
US6974839B2 (en) 2001-03-16 2005-12-13 Dmi Biosciences, Inc. Method of delaying ejaculation
US8604082B2 (en) 2005-12-13 2013-12-10 Trinity Laboratories, Inc. Method to treat premature ejaculation in humans

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6403597B1 (en) 1997-10-28 2002-06-11 Vivus, Inc. Administration of phosphodiesterase inhibitors for the treatment of premature ejaculation
ATE318135T1 (en) * 1999-09-03 2006-03-15 Apbi Holdings Llc USE OF DAPOXETINE, A RAPID ONSET SELECTIVE SEROTONIN UPtake INHIBITOR, FOR THE TREATMENT OF SEXUAL DYSFUNCTION
CA2390903A1 (en) 1999-11-11 2001-05-17 Medicare Management Consultancy Limited Apparatus and method to assist in the diagnosis of premature ejaculation
US6495154B1 (en) * 2000-11-21 2002-12-17 Vivus Inc. On demand administration of clomipramine and salts thereof to treat premature ejaculation
AU2003214800A1 (en) * 2002-01-02 2003-07-24 Ardent Pharmaceuticals, Inc. Method of treating sexual dysfunctions with delta opioid receptor agonist compounds
US7683168B2 (en) * 2005-04-14 2010-03-23 Mount Cook Bio Sciences, Inc. Compositions of novel opioid compounds and method of use thereof
US20080160081A1 (en) * 2006-12-11 2008-07-03 Mutual Pharmaceutical Company, Inc. Alfuzosin formulations, methods of making, and methods of use
US20100092556A1 (en) * 2006-12-11 2010-04-15 Kristin Arnold Alfuzosin formulations, methods of making, and methods of use
US7767248B2 (en) * 2007-02-02 2010-08-03 Overly Iii Harry J Soft chew confectionary with high fiber and sugar content and method for making same

Citations (1)

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WO1992011851A1 (en) * 1990-12-26 1992-07-23 Laragh John H Method and compositions for treatment of sexual impotence

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
WO1992011851A1 (en) * 1990-12-26 1992-07-23 Laragh John H Method and compositions for treatment of sexual impotence

Non-Patent Citations (8)

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"THE MERCK INDEX", 1989, MERCK & CO, INC., RAHWAY, N.J. , USA *
G. BERETTA ET AL.: "EFFECT OF AN ALPHA-BLOCKING AGENT (PHENOXYBENZAMINE) IN THE MANAGEMENT OF PREMATURE EJACULATION", ACTA EUROPAEA FERTILITATIS, vol. 17, no. 1, 1986, pages 43 - 45 *
J.T. CLARK ET AL.: "EVIDENCE FOR THE MODULATION OF SEXUAL BEHAVIOR BY alpha-ADRENORECEPTORS IN MALE RATS", NEUROENDOCRINOLOGY, vol. 41, no. 1, 1985, pages 36 - 43 *
M. SHILON ET AL.: "THE USE OF PHENOXYBENZAMINE TREATMENT IN PREMATURE EJACULATION", FERTILITY AND STERILITY, vol. 42, no. 4, 1984, pages 659 - 661 *
M.M. FOREMAN ET AL.: "THE ROLE OF THE 5-HT2 RECEPTOR IN THE REGULATION OF SEXUAL PERFORMANCE OF MALE RATS", LIFE SCIENCES, vol. 45, no. 4, 1989, pages 1263 - 1270 *
S.T. THOMPSON ET AL.: "PREVENTION OF MALE INFERTILITY: AN UPDATE", THE UROLOGIC CLINICS OF NORTH AMERICA, vol. 21, no. 3, August 1994 (1994-08-01), pages 365 - 376 *
W.D. RATNASOORIYA ET AL.: "IMPAIRMENT OF FERTILITY OF MALE RATS WITH PRAZOSIN", CONTRACEPTION, vol. 41, no. 4, 1990, pages 441 - 447 *
W.D. RATNASOORIYA ET AL.: "THE EFFECT OF TERAZOSIN, A SELECTIVE alpha-ADRENOCEPTOR ANTAGONIST, ON THE FERTILITY OF MALE RATS", MEDICAL SCIENCE RESEARCH, vol. 20, no. 4, 1992, pages 133 - 135 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5922341A (en) * 1997-10-28 1999-07-13 Vivus, Incorporated Local administration of pharmacologically active agents to treat premature ejaculation
US6037360A (en) * 1997-10-28 2000-03-14 Vivus, Incorporated Administration of 5-HT3 receptor antagonists to treat premature ejaculation
US6228864B1 (en) 1997-10-28 2001-05-08 Vivus, Inc. Administration of 5-HT receptor agonists and antagonists, to treat premature ejaculation
US6974839B2 (en) 2001-03-16 2005-12-13 Dmi Biosciences, Inc. Method of delaying ejaculation
US8604082B2 (en) 2005-12-13 2013-12-10 Trinity Laboratories, Inc. Method to treat premature ejaculation in humans

Also Published As

Publication number Publication date
US5707999A (en) 1998-01-13
IT1264965B1 (en) 1996-10-17
EP0728000A1 (en) 1996-08-28
ITMI932412A1 (en) 1995-05-12
JPH09504798A (en) 1997-05-13
ITMI932412A0 (en) 1993-11-12

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