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The extended flexible regimen was not inferior to the 24/4 cyclical regimen in terms of the primary endpoint. It significantly improved symptoms in the interval analysis, and the effects on specific DSR17 symptoms, compared with the cyclical regimen.

A Cuban family with a new congenital dysprothrombinaemia is described. The propositus was a 5-year-old female who presented with umbilical bleeding after birth followed by easy bruising and bleeding tendency throughout her life. The main laboratory features of the defect included prolongation of prothrombin time and partial thromboplastin time. Prothrombin activity was less than 10% in several one- and two-stage systems. However, the staphylocoagulase-complexed prothrombin level and immunologic methods yielded levels of about 50%. The migration of the abnormal prothrombin was more anodic in single and bidimensional immunoelectrophoresis system and did not change by the addition of calcium. Family studies revealed that the father had approximately 50% prothrombin activity and antigen, whereas the mother had 45% prothrombin activity but about 100% prothrombin antigen. We suggest that the propositus is heterozygous for an abnormal prothrombin and heterozygous for true prothrombin deficiency.

Objective: To compare the bleeding pattern in women using ethinylestradiol 20 mcg/ drospirenone 3 mg (EE 20 mcg/DRSP 3 mg) in a 24/4-day cyclic regimen with an extended regimen. Unexpected bleeding/spotting in the extended regimen group was managed by allowing a 4-day hormone-free interval (HFI). Methods: This was a randomized, prospective, open-label, multicenter study. Participants (N = 348) were randomized to receive EE 20 mcg/DRSP 3 mg in either an extended regimen (EE/DRSP es group) or a 24/4-day cyclic regimen (EE/DRSP 24/4 group) and followed for 168 days. In the EE/DRSP es group, a 4-day HFI was allowed whenever unexpected bleeding/ spotting persisted for ≥7 consecutive days. The participants assessed their bleeding daily as "no bleeding," "spotting," or "light," "moderate," or "heavy" bleeding according to a predefined scale. Results: EE/DRSP es group experienced fewer days of bleeding than those using a 24/4 cyclic regimen (P < 0.001). After 168 days, 57.5% of women in the EE/DRSP es group achieved complete amenorrhea (i.e., neither bleeding nor spotting) and 73.9% achieved "no bleeding" (i.e., no bleeding with or without spotting) during the final 28-day interval of the study period. Women in the extended group who instituted the 4-day HFI experienced a 94.1% rate of successful management of unexpected bleeding/spotting. Conclusion: The use of EE 20 mcg/DRSP 3 mg in an extended regimen resulted in high rates of amenorrhea and "no bleeding". Unexpected bleeding/spotting in the EE/DRSP es group could be managed effectively with a 4-day HFI.

Objectives: To evaluate the effectiveness and acceptability of a new vaginal moisturizer composed of a combination of humectants, moisturizers, bioadhesives, and viscosity polymers (sodium hyaluronate 0.1%, polycarbophil 1.5%, carbomer 1.5%, and glycerin 1%) for relief of vulvovaginal symptoms associated with genitourinary syndrome of menopause in Brazilian postmenopausal women. Methods: An open clinical trial was performed with 33 postmenopausal women between 47 and 68 years of age with genitourinary syndrome of menopause symptoms such as vaginal dryness accompanied by pain or discomfort during intercourse. Clinical efficacy in relieving symptoms of genitourinary syndrome of menopause and acceptability were assessed using a Likert scale questionnaire. Efficacy and safety were assessed through gynecological examination, which included visual inspection of the epithelium and vaginal contents, and determination of vaginal pH. Wilcoxon's non-parametric test and paired Student's t-test were used for statistical analyses.Results: After 3 weeks of treatment, most participants reported improvement in GSM symptoms like vaginal dryness (p<0.001), discomfort during or after sexual intercourse (p<0.001), pain during or after sexual intercourse (p<0.001), vaginal odor (p=0.047) and itching (p=0.032) and good acceptability of the moisturizer. There was no alteration in the vaginal health index; however, a reduction in vaginal inflammation (p=0.046) was observed. No clinically significant adverse events were reported by participants. Conclusions: Treatment with non-hormonal vaginal moisturizer for 3 consecutive weeks in postmenopausal women with symptoms of genitourinary syndrome of menopause promoted improvements in vaginal hydration, showing a clinically adequate profile of efficacy and safety, in addition to a satisfactory degree of acceptability.

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