Long-term medical management of uterine fibroids with ulipristal acetate.

OBJECTIVE: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. DESIGN: Double-blind, randomized administration of four 12-week courses of ulipristal acetate. SETTING: Gynecology centers. PATIENT(S): Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding. INTERVENTION(S): Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate. MAIN OUTCOME MEASURE(S): Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain. RESULT(S): Efficacy results, such as bleeding control and fibroid volume reduction, were in line with previously published data. Pain and QoL showed marked improvements from screening, even during the off-treatment intervals. The safety profile of ulipristal acetate was confirmed, and repeated treatment courses did not increase the occurrence of adverse reactions. There were no significant changes in laboratory parameters during the study. The percentage of subjects with endometrial thickness ≥ 16 mm was 7.4% (all subjects) after the first treatment course and returned to below screening levels (4.9%) in subsequent treatment courses. As in previous studies, ulipristal acetate did not increase the occurrence of endometrial features of concern. The frequency of nonphysiological changes did not increase with repeated treatment. They were observed in 17.8% and 13.3% of biopsies after treatment courses 2 and 4, respectively, and were reversible after treatment cessation. CONCLUSION(S): The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate. CLINICAL TRIAL REGISTRATION NUMBER: NCT01629563.

Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids.

OBJECTIVE: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. DESIGN: Double-blind, randomized administration of two 12-week courses of ulipristal acetate. SETTING: Gynecology centers. PATIENT(S): A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding. INTERVENTION(S): Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate. MAIN OUTCOME MEASURE(S): Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain. RESULT(S): In the 5- and 10-mg treatment groups (62% and 73% of patients, respectively) achieved amenorrhea during both treatment courses. Proportions of patients achieving controlled bleeding during two treatment courses were >80%. Menstruation resumed after each treatment course and was diminished compared with baseline. After the second treatment course, median reductions from baseline in fibroid volume were 54% and 58% for the patients receiving 5 and 10 mg of ulipristal acetate, respectively. Pain and QoL improved in both groups. Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events. CONCLUSION(S): Repeated 12-week courses of daily oral ulipristal acetate (5 and 10 mg) effectively control bleeding and pain, reduce fibroid volume, and restore QoL in patients with symptomatic fibroids. CLINICAL TRIAL REGISTRATION NUMBER: NCT01629563 (PEARL IV).

[Changes in anthropometric and metabolic parameters in pregnancy and neonatal physical development during last decades]. / Nesciuju antropometriniu rodikliu, medziagu apykaitos ir naujagimiu fizines bukles pokyciai per pastaruosius desimtmecius.

OBJECTIVE: To evaluate changes in anthropometric and biochemical parameters in pregnancy and their dynamics during last two decades and to determine the association between anthropometric and biochemical parameters, their influence on fetal and neonatal development. MATERIAL AND METHODS: In 1985-2005, anthropometric (height, body mass, weight gain during pregnancy, pelvic measurements, skinfold thicknesses, passive body mass) and biochemical (cholesterol, triglyceride, protein, and iron levels) parameters, their correlation, changes in pregnancy were examined; also the correlations between these parameters and neonatal body mass indices were evaluated. In 1986-1987, 383 pregnant women were examined, in 1998--130, and in 2003-2005--133. RESULTS: During 20 years, the height of examined women increased on an average of 2.5 cm; they became thinner; body mass index decreased. The body composition became similar to "cylinder" shape due to decreased thickness of adipose tissue in the limbs. The dimensions of bony pelvis--external conjugate and bicristal diameters--decreased. Primiparous women became older (1995--22.5 years of age, 2004--27.6). At the beginning of investigation, the weight gain was on an average of 21.9% of body mass before pregnancy (13.3 kg) and at the end--23.9% (14.2 kg). The values of anthropometric parameters vary in a consistent pattern during pregnancy: the lower body mass and body mass index at the beginning of pregnancy, the higher weight gain at the end of pregnancy. Blood serum levels of cholesterol, triglycerides, and especially iron were decreased during the study. CONCLUSIONS: An inverse correlation between body mass index and lipid metabolism in pregnancy was revealed: the higher body mass index was at the beginning of pregnancy, the lower increase in lipid concentration was during pregnancy. At the beginning of investigation as well as after 20 years, women with low body mass index showed the most significant anthropometric and lipid metabolic changes in pregnancy.