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

NCT06176820 | Unknown Phase 2 DMC

• 2 other identifiers: VHAL 001NMRR ID-23-03429-ZXV.
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Menopause Related Conditions; Atrophic Vaginitis; Genitourinary Syndrome of Menopause; Sexual Dysfunction

Keywords

Genitourinary Syndrome of Menopause; Hyaluronic acid; Arginine; Liposome; Vaginal lubricant; Sexual Dysfunction; Vaginal Maturation Index; Vaginal Health Index

Outcome Measures

Primary Outcomes (3)

• The change in VHI Questionnaire score

  Postmenopausal women with symptoms of genitourinary syndrome of menopause (GSM) will be asked to complete a questionnaire reporting their symptoms (vaginal pain, dyspareunia, vaginal dryness, burning, itching, and dysuria), and mark the severity of their symptoms on a 0-3 visual analogue scale (VAS). A score of 0 indicates the absence of a symptom, 1- mild , 2- moderate, 3-severe symptoms. We use the VHAL study questionnaire which is a modification of the validated vulvovaginal symptom questionnaire (VSQ-21).

  The change in VHI Questionnaire score is assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application

• The change in Vaginal Health Index (VHI)

  The clinical evaluation will be performed by gynecologist blinded to the specific study-related information. The clinical data gathered included components of the Vaginal Health Index (VHI) score: elasticity, fluid secretion, potential of hydrogen (pH), epithelial mucosa integrity and moisture components. Each component is scored on a scale of 1 (worst) to 5 (best). The total score is 25 and lower scores indicate more severe atrophy. VHI will be calculated at baseline and 3 months after treatment.

  The change in Vaginal Health Index (VHI) is assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application

• The change in Vaginal Maturation Index (VMI)

  Vaginal smear will be obtained from the upper one-third of the vagina using a spatula and stained according to the Papanicolaou technique at baseline and 3 months after treatment. The cytology samples will be fixed using alcohol and evaluated by an independent, blinded, board-certified pathologist from Department of Pathology, Sarawak General Hospital. The Vaginal Maturation Index (VMI) is determined by calculating the percentage of superficial, intermediate and parabasal epithelial cells on the smear by using this formula \[(1 ×%superficial) + (0.5 × %intermediate) + (0 × %parabasal)\]. The vaginal smear will be destroyed 3 months after the completion of study and will not be used for future study.

  The change in Vaginal Maturation Index (VMI) is assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application

Secondary Outcomes (1)

• Side effects of VHAL gel and vaginal lubricant

  The side effects are assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Arm 1 will apply 2.5 gram of VHAL gel intravaginally using vaginal applicator 2 times per week for 3 months

Drug: Vaginal Gel

Arm 2

ACTIVE COMPARATOR

Arm 2 will apply 2.5 gram of vaginal lubricant intravaginally using vaginal applicator 2 times per week for 3 months

Drug: Vaginal lubricant

Interventions

Vaginal Gel DRUG

Arm 1 will apply 2.5 gram of VHAL gel intravaginally using vaginal applicator 2 times per week for 3 months

Arm 1

Vaginal lubricant DRUG

Arm 2 will apply 2.5 gram of vaginal lubricant intravaginally using vaginal applicator 2 times per week for 3 months

Arm 2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Biological female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women with GSM,
• Postmenopause at least 1 year
• to 80 years old

You may not qualify if:

• Vaginal smear with atypical cell
• The use of hormonal treatment/vaginal treatment in the previous 6 months
• History of hormone-dependent tumor
• Uninvestigated genital bleeding
• Smoker
• Serious disease/ chronic condition that interferes with study compliance

Sponsors & Collaborators

• Sarawak General Hospital: lead

Related Publications (8)

• 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.

  PMID: 25153131 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.

  PMID: 29411644 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.

  PMID: 7799827 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.

  PMID: 33645869 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.

  PMID: 36011183 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.

  PMID: 33801678 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.

  PMID: 35209162 BACKGROUND

• Abdridged Life Tables Malaysia 2019-2021. Department of Statistics Malaysia, Official Portal. 2021

  RESULT

MeSH Terms

Conditions

Atrophic Vaginitis; Sexual Dysfunction, Physiological

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Central Study Contacts

Jun Jiet Ng, MD

CONTACT

+60169550245; njjgbb@gmail.com

Sukanda Jaili, MD

CONTACT

+60178990058; kandot76@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician and Gynecologist, Principal investigator

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share