Clinical trial NCT05464654: Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause
Official title: VABIP Study (Vaginal Biorevitalization With Polydeoxyribonucleotides) for the Improvement of the Genitourinary Syndrome of Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Postmenopausal Disorder
Menopause
Vagina Atrophy
Keywords: Polynucleotides
Genitourinary syndrome of menopause
Postmenopause
Vagina atrophy
Vaginal biorevitalization
Lead sponsor: Hospital Regional 1o de Octubre
Sponsor class: OTHER
Collaborators: name: Hospital General Regional No. 1 IMSS
name: Universidad Nacional Autonoma de Mexico
name: National Polytechnic Institute, Mexico
First posted: 2022-07-19
Enrollment: 136
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline urogenital domain score in the Menopause Rating Scale (MRS) at 3 months
timeFrame: 3 months
measure: Change from baseline Item 9 Menopause Rating Scale (MRS) total score at 3 months
timeFrame: 3 months
measure: Change from baseline Item 10 Menopause Rating Scale (MRS) total score at 3 months
timeFrame: 3 months
measure: Change from baseline Item 11 Menopause Rating Scale (MRS) total score at 3 months
timeFrame: 3 months
measure: Change from baseline Vaginal Maturity Index (VMI) at 3 months
timeFrame: 3 months
measure: Change from baseline Estrogenic Effect at 3 months
timeFrame: 3 months
measure: Change from baseline Oxford grading scale at 3 months
timeFrame: 3 months
measure: Change from baseline vaginal pH at 3 months
timeFrame: 3 months
measure: Change from baseline colposcopic findings at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Study officials:
affiliation: Laboratorio de Bioingenieria de Tejidos, UNAM
name: Juan M Ocampo-Godinez, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Hospital Regional 1o de Octubre, ISSSTE
name: Patricia Loranca-Moreno, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nappi RE, Martini E, Cucinella L, Martella S, Tiranini L, Inzoli A, Brambilla E, Bosoni D, Cassani C, Gardella B. Addressing Vulvovaginal Atrophy (VVA)/Genitourinary Syndrome of Menopause (GSM) for Healthy Aging in Women. Front Endocrinol (Lausanne). 2019 Aug 21;10:561. doi: 10.3389/fendo.2019.00561. eCollection 2019.
citation: The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017 Jul;24(7):728-753. doi: 10.1097/GME.0000000000000921.