SUPPORTING SCIENTIFIC LITERATURE
Scientific Literature Supporting Edox®
In numerous scientific publications describing clinical studies conducted in both the United States and Europe, the combination of Pycnogenol® and L-Arginine has demonstrated efficacy in increasing and enhancing sexual pleasure and performance. A testament to the unassailable scientific evidence supporting the effectiveness of Edox® is that the combination of Pycnogenol® and l-Arginine has been granted a patent (US6,565,851 B2) for the relief of the symptoms of ED. Several of these studies are summarized below.
Treatment of Erectile Dysfunction with Pycnogenol® and L-Arginine
Stanislavov R. et al. Journal of Sex and Marital Therapy, 29(3) 207-213, 2003
40 men (aged 25-45 years) with erectile dysfunction of at least 3 months duration were studied. Initially these men where treated with L-Arginine alone for one month, and a poor response was achieved whereby only 5% of the men experienced normal erectile function. However, when Pycnogenol® was added to the regiment, a significant improvement was noted. After one month of 80 mg of Pycnogenol®/day, 80% of the men reported normal erections. This response improved in a dose dependant fashion whereby increasing the Pycnogenol® dose to 120 mg per day, 92.5% of the men experienced a return of normal erectile function. Furthermore, the study demonstrated that as one increased the dose of Pycnogenol®, the time to achieve an erection decreased and the duration of the erection increased. At a dose of 120 mg of Pycnogenol®, the duration of the erection increased to 15 ± 3 minutes. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The study concluded that “Supplementation with arginine and Pycnogenol® on a regular basis renders individuals with ED to be healthy lovers with a satisfying sexuality”
Prelox For Improvement of Erectile Function: A Review
Lamm S. et al. European Bulletin of Drug Research 11 (3), 29-37, 2003
In a United States study performed by Dr. Steven Lamm, 37 men with erectile dysfunction who where prospectively given therapy with L-Arginine and Pycnogenol® were analyzed. 81% of the men reported that treatment with L-Arginine and Pycnogenol® had improved their ability to engage in sexual activity. An increased IIEF score was reported in 70% of the men with a 10% mean IIEF score increase for the study group as a whole. 73% of the men reported that L-Arginine and Pycnogenol® made it easier to initiate an erection and 70% stated that it made it easier to sustain an erection. A sub analysis of the study population revealed that L-Arginine and Pycnogenol® demonstrated increased efficacy particularly in men who at baseline suffered from moderate and mild erectile dysfunction. In the subgroup of men having the mildest forms of erectile dysfunction, complete restoration of their sexual function was observed. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The authors concluded that L-Arginine and Pycnogenol® “is effective for preserving healthy sexual function in aging men experiencing first signs of lowered erectile performance.”
Improvement of Erectile Function with Prelox: A Randomized Double-Blind, Placebo Controlled, Crossover Trial
Stanislavov R. et al. International Journal of Impotence Research Mar-Apr; 20(2) 173-80, 2008
50 men (aged 30-50 years) with ED were treated in a prospective double blind fashion for one month either with placebo or a combination of L-Arginine and 80 mg of Pycnogenol®. At the conclusion of the initial treatment month, the two groups were crossed over whereby the original placebo group then received L-Arginine and 80 mg of Pycnogenol®, and the initially treated group then received placebo for an additional month. At the conclusion of the treatment period, men treated with L-Arginine and Pycnogenol® achieved normal erectile function (normal defined as an IIEF score of > 25). The treated men reported improved IIEF scores from 11-17 to 26-30. Those treated with placebo did not demonstrate a significant improvement in erectile function. On average it took approximately 5 days for the combination of L-Arginine and Pycnogenol® to improve erectile performance. The mean number of intercourse events more than doubled while on study drug. In the specific IIEF domains of orgasmic function, sexual desire, and intercourse satisfaction, significant improvement was reported. The study also noted that the improvement in erectile function following L-Arginine and Pycnogenol® intake extended beyond the treatment period, suggesting a sustained effect. Furthermore, in this study total testosterone levels also significantly improved in the group of men taking L-Arginine and Pycnogenol®. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The authors concluded that treatment with L-Arginine and Pycnogenol® “seems to offer a safe and very effective alternative to existing medications” for the treatment of erectile dysfunction.
Endothelium –Dependant Vascular effects of Pycnogenol®.
Fitzpatrick D.F et al. Journal of Cardiovascular Pharmacology 32, 509-515, 1998
Pycnogenol® is a very powerful antioxidant that has been shown to stimulate nitric oxide synthesis. Nitric oxide is the key biological compound responsible for penile smooth muscle relaxation and vasodilatation resulting in erectile function.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Scientific Literature Supporting Lady Prelox®
Lady Prelox® improves sexual function in post-menopausal women
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.
Lady Prelox® effects on climacteric symptoms and sexual function in 80 peri-menopausal women aged 40-50 years
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®.
Lady Prelox®improves sexual function in generally healthy women during reproductive years
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.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
