Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause
Condition: Genitourinary Syndrome of Menopause; Postmenopausal Disorder; Menopause; Vagina Atrophy
MeSH terms: Syndrome; Atrophy
Study type: Interventional

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.
    

Intervention name(s): 3 g Polynucleotide vaginal suppositories; Conjugated estrogens cream 1g Tube
Intervention type(s): Drug; Drug
Intervention description(s): 3 g polynucleotide vaginal suppositories were administered nightly for 6 days.; Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.
Other intervention name(s): Tunover®; Generic
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised clinical trial was conducted in 136 postmenopausal women with GSM from the "peri-postmenopause and bone metabolism clinic" of the "Regional Hospital October 1st " of ISSSTE, Mexico, from June to December 2021. The control group (n=64) received local estrogen-based hormonal therapy, applied to the vagina mucosa on Monday, Wednesday, and Friday of each week, for 3 months, while the experimental group (n=72) received local salmon PDRNs on vaginal suppositories, applied solely for six days every night in the first week. The follow-up assessment was done after 3 months.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polynucleotides; Genitourinary syndrome of menopause; Postmenopause; Vagina atrophy; Vaginal biorevitalization