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

Hospital Regional 1o de Octubre

Status: Completed

Conditions: Postmenopausal Disorder; Vagina Atrophy; Menopause; Genitourinary Syndrome of Menopause

Treatments: Drug: 3 g Polynucleotide vaginal suppositories; Drug: Conjugated estrogens cream 1g Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT05464654

012-20170421

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Polynucleotide vaginal suppositories

Experimental group

Description:

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.

Treatment:

Drug: 3 g Polynucleotide vaginal suppositories

Conjugated estrogens cream

Active Comparator group

Description:

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.

Treatment:

Drug: Conjugated estrogens cream 1g Tube