Purpose: Methylergometrine maleate is an ergot alkaloid frequently used in obstetrics for prevention and treatment of post partum haemorrhage. Accidental administration of this medicine to newborns can cause severe effects and should be carefully prevented. The present paper is aimed at describing the main characteristics of cases accidentally exposed to this medicine in Italy before and after Novartis, the manufacturer of Methergin®, a widely used methylergometrine maleate-containing gynecological medication, decided to withdraw the drop preparation from the European market.
View Article and Find Full Text PDFBackground: Studies investigating drug-induced anaemia are relatively scarce and mostly related to specific drugs or patients with specific pathologies.
Objective: To analyse all reports of suspected drug-induced anaemias recorded in the National Pharmacovigilance Database of the Italian Medicines Agency.
Method: The cases of suspected drug-induced anaemias analysed were those retrieved from the Italian National Pharmacovigilance Database from January 2001 to December 2013.
Purpose: The aim of this study was to analyze the cases of gynecomastia associated with α1A-adrenergic receptor antagonists (α1-ARAs) in the Italian spontaneous reporting system database (Rete Nazionale di Farmacovigilanza or RNF) and in the World Health Organization ICSRs database (VigiBase(™)), focusing on tamsulosin use.
Methods: We analyzed the spontaneous reports of gynecomastia related to the use of α1-ARAs and collected from the RNF and from VigiBase(™) up to December 2012. Cases of gynecomastia have been defined as reports associated with gynecomastia according with Medical Dictionary for Regulatory Activities (MedDRA).
Objective To evaluate the impact of a television advertising campaign on the risk of oral ingestion of a topical non-prescription gynaecological preparation containing benzydamine hydrochloride. Design An interrupted time series design with data routinely collected. Setting A National Poison Control Centre.
View Article and Find Full Text PDFWe describe the case of a 30-year-old man with severe oligospermia, caused by partial sperm maturation arrest at spermatidic stage, who was given phytoestrogens. The couple had been trying to conceive for 3 years. The woman was normal at the clinical and endocrinological examination.
View Article and Find Full Text PDFThis prospective, controlled study was performed in order to evaluate whether the location of uterine fibroids may influence reproductive function in women and whether removal of the fibroid prior to conception may improve pregnancy rate and pregnancy maintenance. We examined 181 women affected by uterine fibroids who had been trying to conceive for at least 1 year without success. The main outcome measures were the pregnancy rate and the miscarriage rate.
View Article and Find Full Text PDFObjective: To investigate the effects of soy isoflavones on mood and cognitive function in postmenopausal women.
Design: Randomized, double-blind, cross-over, placebo-controlled trial.
Setting: University Hospital, Milan, Italy; A.
The aim of the present study was to evaluate the efficacy (in terms of induction of uterine bleeding) and safety (in terms of absence of endometrial hyperplasia) of 17alpha-hydroxyprogesterone caproate (17alpha-HPC) in a therapeutic regimen for hormonal replacement after menopause. Fifty postmenopausal patients received hormone replacement therapy (HRT) for 24 weeks. The treatment regimen consisted of standard estrogen replacement therapy at commonly prescribed doses for the prevention of climacteric symptoms and 341 mg of 17alpha-HPC every 30 days.
View Article and Find Full Text PDFBackground: The treatment of pain from episiotomy or from tearing of perineal tissues during childbirth is often unapplied, although discomfort may be severe. We performed a randomized double-blind controlled trial to compare the effectiveness and side-effects of two analgesics in the management of postpartum perineal pain. Patient preference toward the two medications was also analyzed.
View Article and Find Full Text PDFPolycystic ovary syndrome (PCOS) is a common endocrine disorder in woman of reproductive age. Although extensive studies have been performed in past decades to investigate the pathobiological mechanisms underlying the unset of this disease, its etiology remains unknown. Progesterone is a hormone of paramount importance in ovulation, implantation and luteal phase support.
View Article and Find Full Text PDFThe aim of this prospective, randomized trial was to compare the clinical results and the cost-effectiveness of urinary FSH (uFSH) and recombinant FSH (rFSH) in ovarian stimulation for intrauterine insemination (IUI) cycles in polycystic ovary syndrome (PCOS) patients. One-hundred and seventy PCOS infertile patients undergoing IUI were enrolled, and protocols of ovarian stimulation with uFSH or rFSH were randomly assigned. The total number of cycles performed was 379 (182 and 197, respectively).
View Article and Find Full Text PDFObjective: To compare the clinical results and the cost effectiveness of urinary FSH and recombinant FSH in ovarian stimulation for IUI cycles.
Design: Prospective, randomized trial.
Setting: University Hospital, Perugia, and A.
One of the main issues in the management of IVF and embryo transfer techniques is to ensure adequate concentrations of progesterone. The aim of this prospective, randomized study was to compare the effectiveness of 17 alpha -hydroxyprogesterone caproate (17-HPC) administered intramuscularly and intra-vaginal progesterone in gel in luteal phase support in patients undergoing IVF-embryo transfer cycles. A total of 320 patients were randomly treated with either 17-HPC (341 mg i.
View Article and Find Full Text PDFObjective: To determine the effects of 5 years of treatment with soy phytoestrogens on histological characteristics of endometrium in postmenopausal women.
Design: Randomized, double-blind, placebo-controlled study.
Setting: Centre of Perinatal and Reproductive Medicine, Department of Gynecological, Obstetrical, and Pediatric Sciences, University of Perugia, Italy.
Objective: To compare the effectiveness of clomiphene citrate (CC) alone or combined with phytoestrogens (PE) in ovulation induction in patients who had intrauterine insemination in a randomized, double-blind study.
Methods: A total of 134 women aged 25-35 years, who were infertile for at least 2 years and who had oligomenorrhea or amenorrhea associated with a positive menstrual response to the intramuscular progesterone-challenge test were enrolled. They were randomly treated with CC (100 mg daily for 5 days) and CC (100 mg daily for 5 days) in combination with PE (1500 mg daily for 10 days).