title: [Endocrine effect of a new anti-estrogen compound (EGIS-5650, panomifene) in healthy volunteers: phase I/a study].
abstract: Influence of a new Hungarian antiestrogen, panomifene (PAN) was investigated on some hormone levels of 10 postmenopausal healthy women during a partially double-blind placebo controlled phase I/a study. Following a single oral administration of PAN serum estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and prolactin (PROL) levels were measured by RIA at two selected dose levels: 12 mg and 120 mg. The low dose (12 mg) results in an increased E2 level in some cases probably due to the intrinsic estrogenic (agonistic) character of the drug. The high dose (120 mg) seems to have a strong antiestrogenic (antagonistic) action. FSH and LH changed within the normal postmenopausal range at both doses, PROL slightly decreased at 12 mg dose level. During the 14-day follow up, the 120 mg PAN considerably suppressed the PROL secretion proving the antiestrogenic character of the "high" dose. PAN seems to be a safe tamoxifen analogue, the single oral dose of which does not exert any noteworthy (pathogenic) side effect on some hormone levels of healthy women.
authors.affiliation: Országos Onkológiai Intézet, Budapest.
authors.forename: I
authors.initials: I
authors.lastname: Számel
authors.forename: B
authors.initials: B
authors.lastname: Budai
authors.forename: F
authors.initials: F
authors.lastname: Gyergyay
authors.forename: V
authors.initials: V
authors.lastname: Erdélyi-Tóth
authors.forename: J
authors.initials: J
authors.lastname: Kralovánsky
authors.forename: S
authors.initials: S
authors.lastname: Drabant
authors.forename: M
authors.initials: M
authors.lastname: Csörgö
authors.forename: P
authors.initials: P
authors.lastname: Zsarnóczay
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy*; D004311:Double-Blind Method; D004341:Drug Evaluation; D004965:Estrogen Antagonists / Q000008:administration & dosage* / Q000494:pharmacology; D005260:Female; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D010166:Palliative Care; D010919:Placebos; D017698:Postmenopause; D013629:Tamoxifen / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D004965:Estrogen Antagonists; D010919:Placebos; D013629:Tamoxifen; C047993:panomifene