Abstract
Background:
Studies have demonstrated that women with low desire and low excitement have negative feelings regarding their physical and emotional satisfaction, as well as their happiness. In this study, we evaluate the efficacy of Libicare® - a multi-ingredient food supplement - to improve sexual function in postmenopausal women.
Methods:
This was an exploratory, prospective, non-controlled, observational study. Postmenopausal women aged 45-65 with a risk of sexual dysfunction (Female Sexual Function Index (FSFI) < 25.83) were included during routine clinical visits and treated with 2 tablets of Libicare® daily for 2 months. Libicare® is an oral food supplement containing Trigonella foenum graecum, Turnera diffusa, Tribulus terrestris, and Ginkgo biloba dry extracts. Primary endpoint: change vs. baseline in FSFI score. Secondary endpoints: 1) changes in testosterone and serum steroid levels of free testosterone and sex hormone-binding globulin (SHBG) levels and 2) tolerability.
Results:
A total of 29 patients (mean age: 54.69 years) were included. FSFI mean (SD) score showed a significant increase: 20.15 (4.48) vs 25.03 (6.94), baseline vs final; p = 0.0011, paired t-test. Most patients (86.2%) increased their FSFI score. All FSFI domains, except dyspareunia, showed significant increases. The highest increase was observed in the desire domain (p = 0.0004). Testosterone and SHBG levels were assessed in 21 patients. A significant increase in testosterone level was observed: 0.41 (0.26) vs. 0.50 (0.34) pg/mL, baseline vs. final; p = 0.038, Wilcoxon test. 52.4% of patients increased their testosterone levels. Finally, a significant decrease was observed in SHBG level: 85 (32.9) vs. 73 (26.8) nmol/L, baseline vs. final; p = 0.0001; paired t-test. 95.2% of patients decreased their SHBG levels.
Conclusion:
In this pilot study, a significant improvement in sexual function and related hormone levels was observed with Libicare®. Further studies must be conducted to confirm these exciting results.
Trial registration:
Current Controlled Trial ISRCTN12928573 . Date of registration: 28/March/2019. Retrospectively registered.
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