Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1992-01-13
1993-10-05
Wityshyn, Michael G.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
514 21, A61K 3736, A61K 3738, A61K 3743
Patent
active
052505146
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a method of treating non-surgically correctable infertility or sub-fertility in adult men having poor or insufficient semen quality. The invention also relates to the use of human growth hormone (hGH) in the method, either hGH alone or in combination with medical treatment for example gonadotrophins.
There are many causes for infertility or sub-fertility in men, and the medical treatment of this disease is very limited and gives unsatisfactory results.
Depending on the cause of male infertility, the conventional treatment may, for example, comprise either surgery or medical treatment, wherein human chorionic gonadotrophins (hCG), human menopausal gonadotrophin (hMG) (consisting of equal amounts of follicle stimulating hormone, FSH, and luteinizing hormone, LH), luteinizing hormone releasing hormone (LHRH) also called gonadotrophin releasing hormones (GnRH), GnRH analogues or clomiphene citrate may be used.
The invention is based on the discovery that in some cases a connection exists between non-surgically correctable infertility in men and low levels of hGH, and that the poor response obtained in such cases with the above mentioned known treatments might be due to low levels or lack of hGH.
In other cases where low levels or lack of hGH has not been recognized and the above mentioned medical treatments nevertheless have given poor response the present invention has also proven advantageous. Briefly, men with reduced semen quality and with lack of hGH or low to normal level of hGH and where conventional medical treatment has been useless, the treatment with or including hGH according to the invention might be useful.
Adult patients with hGH deficiency (GHD) often complain of fatigue, increased tendency to tiring out, muscle weakness, reduced working capacity and, which is specifically important in this context, of decreased fertility.
It is common practice to subject children having a considerably lower height than normal to a treatment with hGH in order to accelerate growth. When the desired height has been reached no further treatment with hGH is normally carried out due to the scarcity of hGH.
So far, hGH has not been given to adults, even though it is well documented that hGH production and secretion in healthy persons continue in adulthood. One reason for this is that nobody had realized that treatments with hGH would improve semen quality in adults with GHD.
It is known that a connection exists between growth hormone deficiency and poor development of the genitalia of boys. The administration of growth hormone appeared to facilitate growth of genitalia (Laron, Z., and Sarel, R. (1970): Acta Endocrinol. 63: 625-633). Even though hGH improves the growth of genitalia in GHD patients, no investigations have been performed regarding semen quality of such patients.
An object of the invention is to provide a method of treating non-surgically correctable infertility or sub-infertility in adult men having poor or insufficient semen quality and/or demonstrated poor response to known medical treatments.
This object is obtained by the method of the invention, which is characterized in that human growth hormone (hGH) is administered to the male individual to be treated either alone or in combination with medical treatment e.g. gonadotrophins and/or LHRH.
In accordance with a preferred embodiment of the invention, hGH is injected subcutaneously to the male individual to be treated. Other routes of administration can also be used however, such as intramuscular or intravenous injections. In some cases it may be convenient to apply topic preparations, such as lotions or ointments, to penetrate mucous membranes. Also nasal sprays known per se may be used. In fact all forms of administration that will give the necessary uptake of the active compound is useful.
When hGH alone is used the preparation for subcutaneous injections is preferabley used in daily doses containing hGH in amounts of 1-10 IU per m.sup.2 body surface, and more preferably 2-6 IU per m.sup.2 body surface, and still mo
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Clin. Endocrinology, vol. 33, pp. 787-807 (1990).
Agris Cheryl H.
Knudsen Sten L.
Koh Choon P.
Novo Nordisk A S
Wityshyn Michael G.
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