ORIGINAL ARTICLE   

Minerva Ginecologica 2019 December;71(6):434-41

DOI: 10.23736/S0026-4784.19.04466-6

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: English

Prevention of vaginal dryness in perimenopausal women. Supplementation with Lady Prelox®

Maria R. CESARONE ^{1, 2}, Gianni BELCARO ^{1, 2} ✉, Claudia SCIPIONE ^{1, 2}, Valeria SCIPIONE ^{1, 2}, Mark DUGALL ^{1, 2}, Shu HU ³, Roberto COTELLESE ³, Beatrice FERAGALLI ^{1, 2}, Andrea LEDDA ^{1, 2}

¹ IRVINE3 Labs & Pap/Pea Screening Project and the International Irvine Network, Pescara, Italy; ² IAAPS, International Agency for Pharma Standard Supplements, Chieti, Italy; ³ Department of Medical, Oral Sciences and Biotechnologies, G. D’Annunzio University, Pescara, Italy

BACKGROUND: The aim of this pilot registry study was to use a standardized supplement (Lady Prelox®, Horphag Research) - including Pycnogenol®, l-arginine, L-citrulline and rose hip extract - to improve signs and symptoms associated with vaginal dryness in pre and post-menopausal healthy women. A group of women used only a standard management (SM) and a second group added Lady Prelox®.
METHODS: Four groups of women were included in the study. 34 pre-menopausal and 38 post-menopausal women took Lady Prelox®, four tablets daily for 8 weeks and 33 pre-menopausal women and 35 post-menopausal women served as controls.
RESULTS: No safety problems were observed with the supplement that was well tolerated. The subgroups of controls and supplemented subjects were comparable in both the pre- and post-menopausal groups. Among pre-menopausal women, results of the female sexual function index (FSFI) were significantly improved with the supplement in comparison with the control subjects’ group (P<0.05). The results of the FSFI questionnaire for post-menopausal women indicated a significant improvement at 8 weeks with Lady Prelox® (P<0.05) in comparison with controls. Preclinical items (vaginal dryness, pain/discomfort during intercourse, mucus, minimal infections, presence of candida and oxidative stress) were significantly improved (P<0.05) with Lady Prelox®) in comparison to minimal changes with the SM group. These measurements included all women.
CONCLUSIONS: The effects of the supplementation with Lady Prelox® on vaginal dryness were significant. The supplement was well accepted and revealed no side effects or tolerability problems. Further studies are evaluating the effects of Lady Prelox® on other aspects of the menopausal transition that may alter the quality of life of most women in advanced age. A gentle approach with suitable dietary supplementation, represents a promising option for addressing common challenges that women experience in such conditions.

KEY WORDS: Surveys and questionnaires; Dietary supplements; Coitus; Menopause; Pycnogenols; Sexual health