Vaginal Hyaluronic Acid, Arginine and Liposome Gel Versus Vaginal Lubricant in Postmenopausal Women With Genitourinary Syndrome of Menopause

Summary

The goal of this interventional study is to compare the efficacy and safety of vaginal hyaluronic acid, arginine and liposome gel versus vaginal lubricant in the treatment of genitourinary syndrome of menopause in postmenopausal women. The main question it aims to answer is: Is vaginal hyaluronic acid, arginine and liposome gel more effective than vaginal lubricant in the treatment of genitourinary syndrome of menopause in postmenopausal women Participants will be randomized into 2 treatment groups: vaginal hyaluronic acid, arginine and liposome group and vaginal lubricant group. Researchers will compare whether vaginal hyaluronic acid, arginine and liposome group has better improvement than vaginal lubricant group.

Timeline

Start

2024-01-01

Primary completion

2024-07-01

Completion

2024-07-01

Publications

• Background Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and The North American Menopause Society. Climacteric. 2014 Oct;17(5):557-63. doi: 10.3109/13697137.2014.946279. Epub 2014 Aug 25.
• Background Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7.
• Background Ismael NN. A study on the menopause in Malaysia. Maturitas. 1994 Oct;19(3):205-9. doi: 10.1016/0378-5122(94)90073-6.
• Background Harten IA, Evanko SP, Choe CH, Lee EW, Patel BN, Bogdani M, Wight TN, Lee UJ. The extracellular matrix molecules versican and hyaluronan in urethral and vaginal tissues in stress urinary incontinence. Neurourol Urodyn. 2021 Mar;40(3):771-782. doi: 10.1002/nau.24635. Epub 2021 Mar 1.
• Background Nappi RE, Martella S, Albani F, Cassani C, Martini E, Landoni F. Hyaluronic Acid: A Valid Therapeutic Option for Early Management of Genitourinary Syndrome of Menopause in Cancer Survivors? Healthcare (Basel). 2022 Aug 13;10(8):1528. doi: 10.3390/healthcare10081528.
• Background Cieri-Hutcherson NE, Jaenecke A, Bahia A, Lucas D, Oluloro A, Stimmel L, Hutcherson TC. Systematic Review of l-Arginine for the Treatment of Hypoactive Sexual Desire Disorder and Related Conditions in Women. Pharmacy (Basel). 2021 Mar 27;9(2):71. doi: 10.3390/pharmacy9020071.
• Background Liu P, Chen G, Zhang J. A Review of Liposomes as a Drug Delivery System: Current Status of Approved Products, Regulatory Environments, and Future Perspectives. Molecules. 2022 Feb 17;27(4):1372. doi: 10.3390/molecules27041372.
• Results Abdridged Life Tables Malaysia 2019-2021. Department of Statistics Malaysia, Official Portal. 2021

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