Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause
NCT ID: NCT05464654
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2021-06-23
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polynucleotide vaginal suppositories
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.
3 g Polynucleotide vaginal suppositories
3 g polynucleotide vaginal suppositories were administered nightly for 6 days.
Conjugated estrogens cream
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.
Conjugated estrogens cream 1g Tube
Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.
Interventions
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3 g Polynucleotide vaginal suppositories
3 g polynucleotide vaginal suppositories were administered nightly for 6 days.
Conjugated estrogens cream 1g Tube
Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
40 Years
75 Years
FEMALE
No
Sponsors
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Hospital General Regional No. 1 IMSS
OTHER_GOV
Universidad Nacional Autonoma de Mexico
OTHER
National Polytechnic Institute, Mexico
OTHER
Hospital Regional 1o de Octubre
OTHER
Responsible Party
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Principal Investigators
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Juan M Ocampo-Godinez, M.D., Ph.D.
Role: STUDY_DIRECTOR
Laboratorio de Bioingenieria de Tejidos, UNAM
Patricia Loranca-Moreno, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Hospital Regional 1o de Octubre, ISSSTE
Locations
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Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Mexico City, , Mexico
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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012-20170421
Identifier Type: -
Identifier Source: org_study_id
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