NCT05464654

Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause

VABIP Study (Vaginal Biorevitalization With Polydeoxyribonucleotides) for the Improvement of the Genitourinary Syndrome of Menopause

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Hospital Regional 1o de Octubre · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to compare the efficacy of vaginal biorevitalization to improve the genitourinary syndrome of menopause (GSM) between the gold-standard treatment with local estrogen-based hormone therapy versus local salmon polydeoxyribonucleotide (PDRN) therapy.

Detailed description

The aim of the study was to compare the efficacy of vaginal biorevitalization to improve the genitourinary syndrome of menopause (GSM) between the gold-standard treatment with local estrogen-based hormone therapy versus local salmon polydeoxyribonucleotide (PDRN) therapy. Thus, a randomized clinical trial was conducted in 136 first-time postmenopausal women with GSM, from the "peri-postmenopause and bone metabolism clinic" of the "Regional Hospital October 1st " of the "Institute of Security and Social Services for State Workers (ISSSTE)", from June 2021 to December 2021. Participants were referred by the family medicine service or by another service of the hospital. The control group (n=63) received local estrogen-based hormonal therapy, applied topically to the vagina mucosa on Monday, Wednesday, and Friday of each week, for 3 months, while the experimental group (n=70) received local salmon PDRNs on vaginal suppositories, applied solely for six days every night in the first week. Then, experimental group participants were maintained without further treatment up to the control evaluation. The follow-up assessment was done after 3 months. The alterations in the urogenital domain of the MRS score (items 9-11), vaginal maturity index (VMI), vaginal pH, estrogenic effect, floor pelvic contraction capacity, as well as colposcopy findings, were the main outcomes of the study.

Conditions

• Genitourinary Syndrome of Menopause
• Postmenopausal Disorder
• Menopause
• Vagina Atrophy

Interventions

Type	Name	Description
DRUG	3 g Polynucleotide vaginal suppositories	3 g polynucleotide vaginal suppositories were administered nightly for 6 days.
DRUG	Conjugated estrogens cream 1g Tube	Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.

Timeline

• Start date: 2021-06-23
• Primary completion: 2021-11-23
• Completion: 2022-12-31
• First posted: 2022-07-19
• Last updated: 2023-04-11

Locations

1 site across 1 country: Mexico