Effectiveness of the Association N-Palmitoylethanolamine and Transpolydatin in the Treatment of Primary Dysmenorrhea.

Study Objective: To evaluate the effectiveness and safety of the combination of N-palmitoylethanolamine (PEA) and transpolydatin vs placebo in the treatment of primary dysmenorrhea in adolescents and young women.

Design, Setting, And Participants: Randomized treatment and follow-up of 220 cases of primary dysmenorrhea in the Department of Medicine and Health Sciences, Institute of Gynecology and Obstetrics, University of Molise, Italy.

Methods: Between February 2013 and February 2014, we treated 220 young women aged 16 to 24 years who had primary dysmenorrhea: 110 patients were treated with the oral combination of PEA-transpolydatin: 400 mg + 40 mg (1 tablet a day for 10 days from the 24th day of cycle) and 110 patients with placebo (1 tablet a day for 10 days from the 24th day of cycle).

A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence.

Introduction And Hypothesis: Studies have observed a significant heterogeneity in efficacy data for single-incision minislings (SIMS) as surgical treatment for female urinary incontinence (UI). Our study aim was to test the hypothesis that different vaginal kits for SIMS have different long-term outcomes.

Methods: One hundred and twenty women with stress (SUI) or mixed (MUI) UI were enrolled in a multicenter randomized clinical trial (registration number NCT00751088) and treated with three different SIMS (Ajust, MiniArc, or TVT Secur System).

Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial.

Study Objective: To compare single-incision mini-slings (SIMSs) and retropubic tension-free vaginal tape (r-TVT) in terms of the long-term efficacy and safety for the treatment of female stress (SUI) or mixed urinary incontinence (MUI).

Design: Prospective multicenter cohort trial (registration number NCT00751088) (Canadian Task Force II).

Settings: Department of Obstetrics and Gynecology, Italy.

Vulvo-vaginitis in prepubertal girls: new ways of administering old drugs.

Study Objective: To evaluate the effectiveness and safety of local vs systemic antibiotic treatment in the management of recurrent vulvovaginitis in children.

Design: Randomized treatment and follow-up of 90 cases of persistent vulvovaginitis.

Setting: The Department of Medicine and Health Sciences, Institute of Gynecology and Obstetrics, University of Molise, Italy.

A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data.

Objective: Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study was to compare three different SIMS in an ambulatory setting.

Metformin reduces risk of ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome during gonadotropin-stimulated in vitro fertilization cycles: a randomized, controlled trial.

Objective: To test whether metformin administration reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovary syndrome (PCOS) who have been treated with gonadotropins for IVF.

Design: Parallel, randomized, double-blind, placebo-controlled clinical trial.

Setting: Academic departments, general hospital, and IVF centers.

Trisomy 1q42-qter associated with monosomy 6q27-qter: a case report.

Purpose: Partial trisomy 1q42-qter is a rare chromosomal aberration. Most cases arise from de novo unbalanced translocations or from unbalanced inheritance of parental balanced rearrangements.

Methods: Descriptive case report.

Laparoscopic surgery vs laparotomy for early stage endometrial cancer: long-term data of a randomized controlled trial.

Objective: The purpose of the study was to compare the long-term safety and efficacy of laparoscopic surgery and laparotomy approaches to early stage endometrial cancer.

Study Design: This was a prospective long-term extension study of a randomized controlled study that included 84 patients with clinical stage I endometrial cancer (laparoscopic surgery group, 40 women; laparotomy group, 38 women). Safety and efficacy data were evaluated and analyzed by the intention-to-treat principle.

Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study.

Objective: To evaluate long-term efficacy of risedronate in osteoporotic postmenopausal patients with inflammatory bowel disease (IBD).

Design: A prospective, parallel, open-label, 2-year extension study of a randomized, double-blind, 1-year clinical trial. Eighty-one osteoporotic postmenopausal women with IBD were treated with risedronate (n = 40) or placebo (n = 41).

Presurgical assessment of intraabdominal visceral fat in obese patients with early-stage endometrial cancer treated with laparoscopic approach: relationships with early laparotomic conversions.

Study Objective: To evaluate the relationship between intraabdominal visceral fat (IVF) and early conversion from laparoscopy to laparotomy in obese patients.

Design: Prospective study (Canadian Task Force classification II-2).

Setting: Department of obstetrics and gynecology, University "Magna Graecia" of Catanzaro.

Efficacy of risedronate administration in osteoporotic postmenopausal women affected by inflammatory bowel disease.

Patients with inflammatory bowel disease (IBD) have frequently a bone mineral density (BMD) significantly lower than age-matched healthy subjects. The low BMD observed in IBD patients is related also to a higher incidence of bone fractures. In this prospective randomized study we evaluated the effect of 1-year risedronate administration on bone mass and turnover, and on vertebral fractures in osteoporotic postmenopausal women with IBD in remission.

BsmI vitamin D receptor genotypes influence the efficacy of antiresorptive treatments in postmenopausal osteoporotic women. A 1-year multicenter, randomized and controlled trial.

Vitamin D receptor (VDR) gene polymorphisms could be considered one of the factors influencing the efficacy of the anti-osteoporotic treatments. In this multicenter, prospective, randomized and controlled trial we evaluated whether BsmI vitamin D receptor (VDR) genotypes influence the efficacy of antiresorptive treatment regimes (administered alone or in combination) in postmenopausal osteoporotic women. Using restriction endonuclease, we identified the BsmI VDR polymorphism in 1,100 postmenopausal women with osteoporosis.

Laparoscopic colposuspension using sutures or prolene meshes: a 3-year follow-up.

Objective(s): To compare the long-term effectiveness of two different laparoscopic colposuspension procedures.

Study Design: Sixty women affected by genuine stress incontinence (GSI) were enrolled in a prospective randomized controlled trial (RCT) and treated by transperitoneal laparoscopic colposuspension using nonabsorbable sutures (group A) or prolene mesh fixed with tackers or staplers (group B). In each group the subjective and objective failure rates were evaluated at 12, 24, and 36 months after surgery.

Long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with uterine leiomyomas.

Background: Our aim was to evaluate the long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with symptomatic uterine leiomyomas.

Methods: Fifty pre-menopausal women with uterine leiomyomas were treated with leuprolide acetate depot at dose of 3.75 mg/28 days and raloxifene hydrochloride at 60 mg/day for 18 cycles.

Long-term effectiveness of presacral neurectomy for the treatment of severe dysmenorrhea due to endometriosis.

Study Objective: To assess the long-term effectiveness of presacral neurectomy (PSN) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention.

Design: Randomized, controlled trial (Canadian Task Force classification I).

Setting: University-affiliated department of obstetrics and gynecology.

Lipid, glucose and homocysteine metabolism in women treated with a GnRH agonist with or without raloxifene.

Background: Although GnRH analogues are widely used to treat a variety of sex hormone-related diseases, little is known about their effect on metabolism. Therefore, we have evaluated the effect of a GnRH analogue, administered with or without raloxifene, on serum levels of lipoproteins, glucose, insulin and homocysteine (Hcy).

Methods: One hundred premenopausal women with symptomatic uterine leiomyomas were initially enrolled and randomized to receive 3.

Effect of tibolone on breast symptoms resulting from postmenopausal hormone replacement therapy.

Objective: To evaluate the incidence of breast symptoms in a population treated with various hormone replacement therapy (HRT) regimens and to detect the variations in breast symptomatology after HRT changing to tibolone administration.

Methods: This prospective placebo-controlled clinical trial was conducted on healthy women on HRT reporting breast symptoms. A questionnaire was given to each woman to detect breast symptomatology.

Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.

Objective: The purpose of this study was to assess the effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis that was treated with conservative surgical intervention.

Study Design: One hundred forty-one sexually active women of fertile age with chronic severe dysmenorrhea caused by endometriosis were treated with conservative laparoscopic surgery. Patients were assigned randomly to not receive (group A) or receive (group B) presacral neurectomy.

Raloxifene administration in women treated with gonadotropin-releasing hormone agonist for uterine leiomyomas: effects on bone metabolism.

This prospective randomized, single-blind, placebo-controlled clinical trial was performed to evaluate the efficacy of raloxifene in preventing the bone loss associated with GnRH agonist (GnRH-a) administration. One hundred premenopausal women with uterine leiomyomas were treated with leuprolide acetate depot at a dosage of 3.75 mg/d for 28 d and then randomized into two groups to receive raloxifene hydrochloride at 60 mg/d (group A) or placebo (1 tablet/d; group B).

Short-term administration of tibolone plus GnRH analog before laparoscopic myomectomy.

Study Objective: To evaluate whether tibolone modifies the effectiveness of gonadotropin-releasing hormone (GnRH) analog administered before laparoscopic myomectomy.

Design: Prospective, randomized, open, placebo-controlled clinical trial (Canadian Task Force classification I).

Setting: University-affiliated hospital.

Effect of different doses of progestin on uterine leiomyomas in postmenopausal women.

Objective(s): To evaluate the effects of two doses of medroxyprogesterone acetate (MPA) on uterine leiomyoma sizes and on uterine bleeding pattern in postmenopausal women treated with oral hormone replacement therapy (HRT).

Study Design: Thirty natural postmenopausal women affected by uterine leiomyomas were enrolled and treated with oral micronized estradiol (E(2)) at dose of 2 mg per day, and randomized to receive in association MPA at dose of 2.5 mg daily (group A) or of 5 mg daily (group B).

Effect of estrogen replacement plus low-dose alendronate treatment on bone density in surgically postmenopausal women with osteoporosis.

This prospective randomized, double-blind, placebo-controlled, clinical trial was performed to evaluate the effectiveness of estrogens plus low-dose alendronate on bone metabolism. A total of 150 surgically postmenopausal women with osteoporosis were randomized in three groups: group A, micronized E2 (2 mg/d) plus standard-dose alendronate (10 mg/d); group B, micronized E2 plus low-dose alendronate (5 mg/d); and group C, micronized E2 plus placebo (one tablet per day). In all women, bone mineral density (BMD) and serum bone metabolism markers were assessed at admission and every 6 months for 2 yr.