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Genitourinary Syndrome of MenopauseVABIPNCT05464654

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

A study testing 3 g Polynucleotide vaginal suppositories and Conjugated estrogens cream 1g Tube in people with Genitourinary Syndrome of Menopause and Postmenopausal Disorder, run by Hospital Regional 1o de Octubre at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years, women only
What is being tested?
3 g Polynucleotide vaginal suppositories and Conjugated estrogens cream 1g Tube
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteMexico
Study dates
23 Jun 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

Mexico1 site

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

    Mexico City, 07300

Other trials in Mexico

About this study

Official title: VABIP Study (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.

Read the 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.

Being tested
3 g Polynucleotide vaginal suppositories, Conjugated estrogens cream 1g Tube
Keywords
Polynucleotides, Genitourinary syndrome of menopause, Postmenopause, Vagina atrophy, Vaginal biorevitalization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 g Polynucleotide vaginal suppositoriesDrug

    Also called Tunover®

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

  • Conjugated estrogens cream 1g TubeDrug

    Also called Generic

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

Study groups in NCT05464654
Study groupRoleWhat they receive
Polynucleotide vaginal suppositoriesExperimentalIn 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.
Receives: Drug: 3 g Polynucleotide vaginal suppositories
Conjugated estrogens creamActive comparatorIn 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.
Receives: Drug: Conjugated estrogens cream 1g Tube

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

  6. Change from baseline Estrogenic Effect at 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)]

    Measured: 3 months

  7. Change from baseline Oxford grading scale at 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.

    Measured: 3 months

  8. Change from baseline vaginal pH at 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.

    Measured: 3 months

  9. Change from baseline colposcopic findings at 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start23 Jun 2021
  3. Primary completion23 Nov 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464654
Sponsor's protocol ID
012-20170421
Acronym
VABIP
Status last verified
Apr 2023
First submitted
15 Jul 2022
Last updated
11 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause. 2020 Sep;27(9):976-992. doi: 10.1097/GME.0000000000001609.

    PubMed 32852449

  • Schneider HP, Heinemann LA, Rosemeier HP, Potthoff P, Behre HM. The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints. Climacteric. 2000 Mar;3(1):59-64. doi: 10.3109/13697130009167600.

    PubMed 11910611

  • Heinemann K, Assmann A, Mohner S, Schneider HP, Heinemann LA. [Reliability of the Menopause Rating Scale (MRS): Investigation in the German population]. Zentralbl Gynakol. 2002 Mar;124(3):161-3. doi: 10.1055/s-2002-32268. German.

    PubMed 12070795

  • Schneider HP, Rosemeier HP, Schnitker J, Gerbsch S, Turck R. Application and factor analysis of the menopause rating scale [MRS] in a post-marketing surveillance study of Climen. Maturitas. 2000 Dec 29;37(2):113-24. doi: 10.1016/s0378-5122(00)00177-8.

    PubMed 11137330

  • Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.

    PubMed 15345062

  • Weber MA, Limpens J, Roovers JP. Assessment of vaginal atrophy: a review. Int Urogynecol J. 2015 Jan;26(1):15-28. doi: 10.1007/s00192-014-2464-0. Epub 2014 Jul 22.

    PubMed 25047897

  • McCracken JM, Balaji S, Keswani SG, Hakim JC. An Avant-Garde Model of Injury-Induced Regenerative Vaginal Wound Healing. Adv Wound Care (New Rochelle). 2021 Apr;10(4):165-173. doi: 10.1089/wound.2020.1198. Epub 2020 Aug 10.

    PubMed 32602816

  • Chung HS, Lee HS, Park K. Estrogen modulates epithelial progenitor cells in rat vagina. Investig Clin Urol. 2021 May;62(3):349-353. doi: 10.4111/icu.20200513. Epub 2021 Apr 2.

    PubMed 33834644

  • Rahn DD, Carberry C, Sanses TV, Mamik MM, Ward RM, Meriwether KV, Olivera CK, Abed H, Balk EM, Murphy M; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen for genitourinary syndrome of menopause: a systematic review. Obstet Gynecol. 2014 Dec;124(6):1147-1156. doi: 10.1097/AOG.0000000000000526.

    PubMed 25415166

  • 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.

    PubMed 31496993

  • 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.

    PubMed 28650869

Questions about this trial

What is this clinical trial studying?

A study testing 3 g Polynucleotide vaginal suppositories and Conjugated estrogens cream 1g Tube in people with Genitourinary Syndrome of Menopause and Postmenopausal Disorder, run by Hospital Regional 1o de Octubre at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline urogenital domain score in the Menopause Rating Scale (MRS) at 3 months (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464654, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.

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