Genetic Aspects of Vaginal Aging
Epigenetic Profile of Vaginal Epithelial Cells in Postmenopausal Women and as a Result of Local Hormone Therapy, Assessed on the Basis of the Analysis of DNA Methylation Level and Expression of TET 1-3 Genes in Terms of the Aging Process
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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Warsaw, Poland, 01-004
- Centrum Medyczne "ŻELAZNA"
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- informed consent of the patient
- patient's age> 18 years
- POP-Q < = II
- non-smoker
- without prior vaginal surgery
Exclusion Criteria:
- refusal to participate in the study
- POP-Q > II
- smoking
- internal diseases (diabetes, disorders of the thyroid gland, obesity, cancer, malnutrition, exhaustion)
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
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Premenopausal women (PREM)
Control group
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Postmenopausal women (POSMA)
Test group A : postmenopausal women not treated with topical estrogens
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Postmenopausal women (POSMB)
Test group B: postmenopausal women treated with topical estrogens
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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5-hmC content
Time Frame: 30 days
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- 5-hmC content and 5-mC increase in tissues with urogenital atrophy
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30 days
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TET expressiion
Time Frame: 30 days
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- TET expression in tissues with urogenital atrophy
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30 days
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Changes in the 5-hmC
Time Frame: 30 days
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- changes in the 5-hmC content and the 5-mC content in vaginal cells after hormone therapy (topical application of estrogens)
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30 days
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TET expression change
Time Frame: 30 days
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- TET expression change after hormone therapy
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30 days
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Promoter methylation of specific genes involved in the aging process
Time Frame: 30 days
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- Methylome analysis to identify promoter methylation of specific genes involved in the aging process
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30 days
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
- Palma F, Volpe A, Villa P, Cagnacci A; Writing group of AGATA study. Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. Maturitas. 2016 Jan;83:40-4. doi: 10.1016/j.maturitas.2015.09.001. Epub 2015 Sep 14.
- Borkowska J, Domaszewska-Szostek A, Kolodziej P, Wicik Z, Polosak J, Buyanovskaya O, Charzewski L, Stanczyk M, Noszczyk B, Puzianowska-Kuznicka M. Alterations in 5hmC level and genomic distribution in aging-related epigenetic drift in human adipose stem cells. Epigenomics. 2020 Mar;12(5):423-437. doi: 10.2217/epi-2019-0131. Epub 2020 Feb 7.
- Truong TP, Sakata-Yanagimoto M, Yamada M, Nagae G, Enami T, Nakamoto-Matsubara R, Aburatani H, Chiba S. Age-Dependent Decrease of DNA Hydroxymethylation in Human T Cells. J Clin Exp Hematop. 2015;55(1):1-6. doi: 10.3960/jslrt.55.1.
- Gorodeski GI. Aging and estrogen effects on transcervical-transvaginal epithelial permeability. J Clin Endocrinol Metab. 2005 Jan;90(1):345-51. doi: 10.1210/jc.2004-1223. Epub 2004 Oct 13.
- Li D, Guo B, Wu H, Tan L, Lu Q. TET Family of Dioxygenases: Crucial Roles and Underlying Mechanisms. Cytogenet Genome Res. 2015;146(3):171-80. doi: 10.1159/000438853. Epub 2015 Aug 21.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- 1 (Mobile Health and Wellness Program)
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