Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1996-04-16
1998-01-13
Cook, Rebecca
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
A61K 31505
Patent
active
057079994
DESCRIPTION:
BRIEF SUMMARY
This is a 371 of PCT/EP94/03661 filed Nov. 8, 1994.
The present invention relates to the use of .alpha.1 blockers in the treatment of premature ejaculation.
BACKGROUND OF THE INVENTION
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. 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 as a result of .alpha.1-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).
SUMMARY OF THE INVENTION
Now it has been found that two specific .alpha.1-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 to use alfuzosine and terazosine and the pharmaceutically acceptable salts thereof for the preparation of a medicament useful for the treatment of psychogenic premature ejaculation.
DESCRIPTION OF PREFERRED EMBODIMENTS
Alfuzosine and terazosine are al blockers used in the treatment of hypertension or in the symptomatic treatment of benign prostatic hyperplasia. Up to now no reference appears in literature about any possible use thereof in the treatment of psychogenic premature. ejaculation, particularly in patients resistant to psychotherapy.
In the following, the clinical evaluation of alfuzosine and terazosine is illustrated.
107 Patients complaining of psychogenic premature ejaculation were tested during 2 years. Age range was 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 2 mg three times per day, terazosine 5 mg once a day (the dosage was gradually reached starting from 1 mg/day) and vitamin C 500 mg two times per day.
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 whether or not they were satisfacted by the activity of the drugs: i.e. whether 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 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
REFERENCES:
Medical Science Research, vol. 20, No. 4, 1992, pp. 133-135, "The Effect of Terazosin, A Selective Alpha-Adrenoceptor Antagonist, on the Fertility of Male Rats" by W.D. Ratnasooriya et al.
ACTA Europaea Fertilitatis, vol. 17, No. 1, 1986, pp. 43-45, "Effect of an Alpha-Blocking Agent (Phenoxybenzamine) in the Management of Premature Ejaculation" by G. Beretta et al.
Fertility and Sterility, vol. 42, No. 4, 1984, pp. 659-661, "The Use of Phenoxybenzamine Treatment in Premature Ejaculation" by M. Shilon et al.
Contraception, vol. 41, No. 4, 1990, pp. 441-447, "Impairment of Fertility of Male Rats with Prazosin" by W.D. Ratnasooriya et al.
Neuroendocrinology, vol. 41, No. 1, 1985, pp. 36-43, "Evidence for the Modulation of Sexual Behaviour by Alpha-Adrenoreceptors in Male Rats" by J.T. Clark et al.
Life Sciences. vol. 45, No. 14, 1989, pp. 1263-1270, "The Role of the 5-HT2 Receptor in the Regulation or Sexual Performance of Male Rats" by M.M. Foreman et al.
The Merck Index, 1989, Merck & Co., Inc., Rahway, NJ, USA, pp. 40-41 and pp. 1441-1442.
The Urologic Clinics of North America, vol. 21, No. 3, Aug. 1994, pp. 365-376, "Prevention of Male Infertility: An Update" by S.T. Thompson et al.
Cook Rebecca
Synthelabo
LandOfFree
Use of alfuzosin or terazosin in the treatment of premature ejac does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Use of alfuzosin or terazosin in the treatment of premature ejac, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Use of alfuzosin or terazosin in the treatment of premature ejac will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-326486