Bottari A et al., Panminerva Med 2012
The aim of this pilot registry study was to evaluate the effectiveness of Lady Prelox® for improving/controlling sexual dysfunction (SD) in post-menopausal women with a healthy circulation.The Lady Prelox® and control groups were comparable at inclusion with regard to the Female Sexual Function Index (FSFI) score with 36 women (50.1 ± 3.1 years) and 39 women (51.2 ± 2.3 years), respectively. After four weeks treatment there was a significant improvement in the group, which sustained until completion of the eight-week trial period. Minor, non-significant changes were observed in controls. The median FSFI score at inclusion was 44.6 and significantly increased to 70.9 after four weeks and remained at this level after eight weeks. In the control group the total FSFI was 44.1 at inclusion, and reached 45.0 after four weeks and 47.4 after eight weeks, respectively. The treatment with Lady Prelox® was comparatively more effective than placebo.
Stanislavov et. al 2014
The aim of this study was to evaluate a dietary supplement Lady Prelox®for climacteric symptoms and sexual function in peri-menopausal women in double-blind, placebo-controlled fashion. Eighty women aged 40-50 years, presenting with both moderate sexual function impairment as well as menopausal symptoms were recruited at the university hospital for this study. Following medical examination suitable women were randomly assigned to either treatment for eight weeks with Lady Prelox® group or with placebo. Menopausal symptoms were explained using the established Women’s Health Questionnaire and Kupperman’s menopause rating scale. Women’s sexual function was studied using the female sexual function index (FSFI). In placebo-treated women the total FSFI score non-significantly increased from baseline 12.4 ± 2.3 to 14.4 ± 2.8 after four weeks and 16.6 ± 2.3 after eight weeks. In the Lady Prelox® group the FSFI score at baseline was moderately higher than in the placebo group (16.5 ± 2.9) and increased to 21.7 ± 2.8 and 26.5 ± 3.3 after four and eight weeks, respectively. The scores for Lady Prelox® after four and eight weeks of treatment were statistically significantly higher than in the placebo group. A detailed examination of the different domains of the FSFI suggests that Lady Prelox® significantly improves all “desire”, “arousal”, “lubrication”, “orgasm”, “satisfaction” and “pain”. Comparatively, the domains “orgasm” and “satisfaction” were found to improve most prominently. Climacteric symptoms were found to significantly improve with Lady Prelox®, after four and eight weeks of treatment. A series of symptoms was found to improve significantly already after four weeks as compared to the group of women taking placebo: hot flashes, night sweats, sleep problems, irritability, depressed mood and mental focus. These improvements were maintained until completion of the trial after eight weeks. All symptoms except “depressions” of the “Women Health Questionnaire” were significantly less pronounced than in the placebo group. Symptoms responding particularly well to Lady Prelox® were related to cognition (mental focus) and “anxiety/fears”. Interestingly, the symptom most influenced by the administration of placebo, was the self-perceived attraction. Safety evaluations suggest that Lady Prelox® and placebo were well tolerated and none of the subjects experienced side-effects. Blood laboratory testing confirms the safety of the product. A small yet statistical significant lowering of systolic and diastolic blood pressure was noticed with Lady Prelox® after eight weeks. Blood pressure, BMI, lipid profile and TAC significantly improved in the group receiving Lady Prelox®.
Belcaro et al., Minerva Ginecologica 2013
The aim of this study was to evaluate the effects of Lady Prelox® for improving sexual function in healthy women presenting with moderate signs of sexual function impairment. The women investigated in this study were aged 37 to 45 years, none having reached menopause and all were of general good health. The Lady Prelox® and placebo-treated groups were comparable at inclusion as judged from the short form of to the Female Sexual Function Index (FSFI) score with 49 women aged (40.4 ± 2.3 years) and 51 women (41.3 ± 2.2 years), respectively. Women were treated for eight weeks with either Lady Prelox® or placebo tablets with identical appearance. In placebo-treated women the FSFI score increased non-significantly from baseline 17.9 ± 2.3 to 23.5 ± 1.8 after four weeks and 23.5 ± 2.2 after trial completion after eight weeks. The group of women treated with Lady Prelox® presented with an average baseline FSFI score of 15.0 ± 2.7, which increased to 28.3 ± 2.4 after four weeks treatment and reached 33.9 ± 2.7 after eight weeks. The scores observed in the Lady Prelox® treated group were statistically significant versus baseline values as well as versus the placebo-group at both time points, four and eight weeks, respectively. Conclusion: All domains of the female sexual function score showed improvements with Lady Prelox® of which categories “dryness” and “sexual desire” and “satisfaction”, also related to “sexual satisfaction in the relationship”, were especially noticeable. The intake of Lady Prelox® and corresponding placebo was well tolerated and women did not experience significant side effects attributable to the study tablets.
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