title: Chronic treatment with CV 205-502 restores the gonadal function in hyperprolactinemic males.
abstract: The aim of this study was to evaluate the effects of a chronic treatment with the non-ergot-derived dopamine agonist quinagolide (CV 205-502) on sexual and gonadal function in hyperprolactinemic males. Thirteen males with macroprolactinoma and one with microprolactinoma were treated with CV 205-502 at the dose of 0.15-0.6 mg/day for 6-24 months. Baseline prolactin (PRL) was 464 +/- 75.7 microg/l. All the patients suffered from libido impairment, five of reduced sexual potency, six had infertility and in four bilateral induced galactorrhea was shown. The semen analysis revealed a severe oligoasthenospermia with reduced sperm count, motility and forward progression, with an abnormal morphology and decreased viability. A significant reduction of serum PRL levels (nadir PRL = 12.3 +/- 5.4 microg/l) was obtained during the treatment. Normalization of prolactinemia was reached in 13 of the 14 patients after 3 months. After 1 year, a significant improvement of sperm parameters, in terms of increase of number (from 5600 +/- 111 to 20,564 +/- 587 mm3), motility at 1 h (from 24.8 +/- 0.1 to 52.6 +/- 0.5%), forward progression (from 24 +/- 1.4 to 62.3 +/- 2.9%) and normal morphology (from 53.8 +/- 2.5 to 62.2 +/- 2.4%), was recorded. In addition, a significant increase of serum follicle-stimulating hormone (from 5.3 +/- 0.6 to 7.8 +/- 0.4 U/l), luteinizing hormone (from 4.4 +/- 0.5 to 7.7 +/- 0.4 U/l) and testosterone (from 3.4 +/- 0.4 to 4.7 +/- 0.2 microg/l) was recorded. A significant increase of luteinizing hormone (9.4 +/- 0.7 U/l) and testosterone (5.2 +/- 0.4 microg/l), as well as a further improvement of sperm parameters, was found after 2 years of therapy. Sellar computed tomography and/or magnetic resonance showed a considerable shrinkage (> or = 30%) of tumoral mass in 8 out of 13 patients with macroprolacinoma. Side effects were recorded in only one patient. In conclusion, the treatment with CV 205-502 normalizing PRL levels improves gonadal and sexual function and fertility in males with prolactinoma, providing good tolerability and excellent patient compliance to medical treatment. This result demonstrates that the impairment of gonadal function in hyperprolactinemic patients is a functional modification.
authors.affiliation: Department of Molecular and Clinical Endocrinology and Oncology, Federico II University, Naples, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Colao
authors.forename: M
authors.initials: M
authors.lastname: De Rosa
authors.forename: F
authors.initials: F
authors.lastname: Sarnacchiaro
authors.forename: A
authors.initials: A
authors.lastname: Di Sarno
authors.forename: M L
authors.initials: ML
authors.lastname: Landi
authors.forename: E
authors.initials: E
authors.lastname: Iervolino
authors.forename: S
authors.initials: S
authors.lastname: Zarrilli
authors.forename: B
authors.initials: B
authors.lastname: Merola
authors.forename: G
authors.initials: G
authors.lastname: Lombardi
mesh_terms: D000634:Aminoquinolines / Q000009:adverse effects / Q000494:pharmacology*; D000818:Animals; D018491:Dopamine Agonists / Q000494:pharmacology*; D006801:Humans; D006966:Hyperprolactinemia / Q000097:blood / Q000150:complications / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D009845:Oligospermia / Q000209:etiology; D010911:Pituitary Neoplasms / Q000150:complications; D011388:Prolactin / Q000097:blood; D015175:Prolactinoma / Q000150:complications; D013076:Sperm Count / Q000187:drug effects; D013094:Spermatozoa / Q000187:drug effects / Q000502:physiology; D013737:Testis / Q000187:drug effects* / Q000503:physiopathology*; D013997:Time Factors
chemical_list: D000634:Aminoquinolines; D018491:Dopamine Agonists; C046650:quinagolide; D011388:Prolactin