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

Not Applicable

Completed

• Conditions: Genitourinary Syndrome of Menopause; Menopause; Postmenopausal Disorder; Vagina Atrophy
• Interventions: Drug: Conjugated estrogens cream 1g Tube; Drug: 3 g Polynucleotide vaginal suppositories

• Registration Number: NCT05464654
• Lead Sponsor: Hospital Regional 1o de Octubre

Brief 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.

Study Timeline

• Study Start: 2021-06-23
• Primary Completion: 2021-11-23
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-08
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

• First-time patients with the diagnosis of Genitourinary Syndrome of Menopause with an MRS > 5 in the urogenital domain, with alterations in the vaginal maturity index (VMI).

Exclusion Criteria

• Incomplete clinical records.
• History of prolonged use of steroids.
• Use of alternative local therapies applied in the vagina's mucosa.
• Use of local therapies with vaginal suppositories for any reason 15 days before the beginning of the study.
• Clinical evidence of infectious cervical-vaginitis or vulvovaginitis.
• Evidence of urinary tract infection (UTI).
• Lack of adherence to medical treatment.
• Diagnosis of cancer.
• Diagnosis of depression.
• Diagnosis of uncontrolled primary or secondary immunodeficiencies.
• Allergies to any of the medications administered.
• BIRADS >2 or high risk of developing breast cancer, ovarian cancer or endometrial cancer.
• Use of oral hormonal or non-hormanl therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conjugated estrogens cream	Conjugated estrogens cream 1g Tube	In this arm 64 first-time participants of the "peri-postmenopause and bone metabolism clinic" of the "Regional Hospital October 1st " of ISSSTE Mexico, were randomly enrolled to be treated with the gold-standard treatment with local estrogen-based hormone therapy.
Polynucleotide vaginal suppositories	3 g Polynucleotide vaginal suppositories	In this arm 72 first-time participants of the "peri-postmenopause and bone metabolism clinic" of the "Regional Hospital October 1st " of ISSSTE Mexico, were randomly enrolled to be treated with local salmon polydeoxyribonucleotide (PDRN) therapy.

Primary Outcome Measures

Name	Time	Method
Change from baseline urogenital domain score in the Menopause Rating Scale (MRS) at 3 months	3 months	Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. Items 9, 10 and 11 evaluate the urogenital domain. 0 points were considered asymptomatic, 1point indicated mild symptoms, 2-3 points moderate symptoms and \> 4 indicated severe symptoms.
Change from baseline colposcopic findings at 3 months	3 months	The presence or absence of vaginal folds, paleness and vaginal lesions were colposcopic findings that were evaluated as nominal dichotomous variables. Lugol's staining was performed during colposcopy. The degree of Lugol's staining was evaluated as an ordinal variable with 4 degrees, depending on the intensity of staining of the vaginal mucosa.
Change from baseline Item 9 Menopause Rating Scale (MRS) total score at 3 months	3 months	Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. Item 9 assesses the severity of sexual problems, including changes in libido, sexual activity, and dyspareunia. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline Item 10 Menopause Rating Scale (MRS) total score at 3 months	3 months	Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. Item 10 assesses the severity of urinary problems such as polyuria, urinary urgency, bladder instability, and urinary incontinence. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline Item 11 Menopause Rating Scale (MRS) total score at 3 months	3 months	Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. Item 11 assesses the severity of vaginal dryness. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline Vaginal Maturity Index (VMI) at 3 months	3 months	The vaginal maturation index (VMI) is used to assess the hormonal status of the vaginal epithelium, which quantifies the proportions of cell types in the vaginal epithelium. The VMI was evaluated through vaginal cytology, where the percentage of basal/parabasal, intermediate and superficial cells were calculated.
Change from baseline Oxford grading scale at 3 months	3 months	The Oxford grading scale evaluates the contraction capacity of the muscles of the pelvic floor. It was used at the time of vaginal examination. 0 points meant no contraction , 1 point a flicker contraction, 2 points a weak contraction, 3 points a moderate contraction, 4 points a good contraction, and 5 points a strong contraction.
Change from baseline Estrogenic Effect at 3 months	3 months	The estrogenic effect is used to evaluate the local action of estrogens in the vaginal epithelium. The higher value, it means that it is having a greater trophic effect due to local estrogen stimulation. To calculate this outcome, it was used the next formula: Estrogenic effect= \[(% of basal/parabasal cells\*0)+(% of intermediate cells\*0.5)+(% of superficial cells\*1)\]
Change from baseline vaginal pH at 3 months	3 months	Vaginal pH tests measure the acidity of the vagina. A normal vaginal pH value was considered when it was between 4.0 and 5.

Trial Locations

Locations (1)

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE; 🇲🇽 Mexico City, Mexico