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Completed

NCT Number: NCT05464654

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

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.

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Key information

Conditions

Genitourinary Syndrome of Menopause Menopause Postmenopausal Disorder Vagina Atrophy

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE

Mexico City, 07300, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3 g Polynucleotide vaginal suppositories

Drug

3 g polynucleotide vaginal suppositories were administered nightly for 6 days.

Other names: Tunover®

Conjugated estrogens cream 1g Tube

Drug

Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.

Other names: Generic

Primary outcomes

  1. Change from baseline urogenital domain score in the Menopause Rating Scale (MRS) at 3 months

    Time frame: 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.

  2. Change from baseline Item 9 Menopause Rating Scale (MRS) total score at 3 months

    Time frame: 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.

  3. Change from baseline Item 10 Menopause Rating Scale (MRS) total score at 3 months

    Time frame: 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.

  4. Change from baseline Item 11 Menopause Rating Scale (MRS) total score at 3 months

    Time frame: 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.

  5. Change from baseline Vaginal Maturity Index (VMI) at 3 months

    Time frame: 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.

  6. Change from baseline Estrogenic Effect at 3 months

    Time frame: 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)]

  7. Change from baseline Oxford grading scale at 3 months

    Time frame: 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.

  8. Change from baseline vaginal pH at 3 months

    Time frame: 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.

  9. Change from baseline colposcopic findings at 3 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Regional 1o de Octubre

Other

Collaborators

  • Hospital General Regional No. 1 IMSS
  • National Polytechnic Institute, Mexico
  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

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

Acronym: VABIP

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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