Menopause Clinical Trial
Official title:
The Menopausal Hot Flush: Cutaneous Vascular and Sudomotor Function and Structure in Symptomatic Women
NCT number | NCT06222073 |
Other study ID # | MenoSkin |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | December 31, 2024 |
The aim of this research is to 1) test how the skin blood vessels and sweat glands function in women who experience hot flushes by using skin microdialysis to deliver small amounts of substances to the skin that cause increased skin blood flow and sweating, and 2) examine the structure of the skin blood vessels and sweat glands in the skin of women who experience hot flushes by taking a very small skin biopsy. Any changes in the function or structure of the skin blood vessels or sweat glands in women with hot flushes would increase our understanding of what causes hot flushes and help to design effective treatments.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Aged >45 years for the postmenopausal cohort and aged 18-30 years for the premenopausal cohort - Female - Amenorrhoeic for >6 months (postmenopausal criteria) - >4 hot flushes per day (symptomatic postmenopausal criteria) - Eumenorrhoeic with regular menstrual cycles (premenopausal criteria) - Healthy - Non-smoker - BMI 18-30 kg/m2 - No history of cardiovascular or respiratory disease - No history of metabolic disease e.g. type II diabetes - Drink <14 units of alcohol per week - Not taking any medication or treatments to alleviate hot flushes Exclusion Criteria: - Aged < 18 years or 31-44 years - Male - Smokers - Medical history of cardiovascular/respiratory disease - Medical history of metabolic disease e.g. type II diabetes - Drink >15 units of alcohol per week - On medication or treatments to alleviate hot flushes or have taken such medication/treatment within the previous 6 months - BMI of <18 or >30 kg/m2 - Vaccination (<1 week) due to induced systemic inflammatory reaction - Local forearm infection - Allergy to local anaesthetic/Marcain/amide-group anaesthetics - Pregnant |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool John Moores University | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Liverpool John Moores University | British Heart Foundation |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin function/responsiveness | The non-dominant forearm will be inserted with 3 cutaneous microdialysis membranes. Each of the membranes will be perfused with either of the following (randomly assigned to the three sites); increasing doses of Acetylcholine, Sodium Nitroprusside (SNP) or calcitonin gene-related peptide (CGRP) to stimulate skin blood flow (and sweating) which will be assessed using laser Doppler probes housed directly over the membrane sites. The dose-response curves for skin blood flow will be mathematically modelled via non-linear regression curve fitting. The maximum responses and the effective concentration causing 50% of the maximal response (EC50) will be calculated from the nonlinear regression modelling. | Baseline (visit 1) | |
Primary | Sweat gland function/responsiveness | The non-dominant forearm will be inserted with 3 cutaneous microdialysis membranes. Each of the membranes will be perfused with either of the following (randomly assigned to the three sites); increasing doses of Acetylcholine, Sodium Nitroprusside (SNP) or calcitonin gene-related peptide (CGRP) to stimulate sweating (and skin blood flow) which will be assessed using laser Doppler probes housed directly over the membrane sites. The dose-response curves for sweating will be mathematically modelled via non-linear regression curve fitting. The maximum responses and the effective concentration causing 50% of the maximal response (EC50) will be calculated from the nonlinear regression modelling. | Baseline (visit 1) | |
Primary | Oestradiol | A venous blood sample will be taken and analysed to establish the oestradiol level (pg/mL). | Baseline (visit 1) | |
Primary | Interleukin-6 (IL-6) | A venous blood sample will be taken to assess circulating inflammatory markers/cytokines.
Interleukin-6 (IL-6) will be measured (pg/mL) using an ELISA. |
Baseline (visit 1) | |
Primary | Interleukin-8 (IL-8) | A venous blood sample will be taken to assess circulating inflammatory markers/cytokines.
Interleukin-8 (IL-8) will be measured (pg/mL) using an ELISA. |
Baseline (visit 1) | |
Primary | Tumour Necrosis Factor alpha (TNF-a) | A venous blood sample will be taken to assess circulating inflammatory markers/cytokines.
TNF-a (IL-8) will be measured (pg/mL) using an ELISA. |
Baseline (visit 1) | |
Primary | Prostaglandin E2 | A venous blood sample will be taken to assess circulating inflammatory markers/cytokines.
Prostaglandin E2 will be measured (pg/mL) using an ELISA. |
Baseline (visit 1) | |
Primary | C-reactive Protein (CRP) | A venous blood sample will be taken to assess circulating inflammatory markers/cytokines.
Prostaglandin E2 will be measured (mg/L) using an ELISA. |
Baseline (visit 1) | |
Primary | Calcitonin Gene Related Peptide (CGRP) | A venous blood sample will be taken to assess circulating inflammatory markers/cytokines.
CGRP will be measured (pg/mL) using an ELISA. |
Baseline (visit 1) | |
Primary | Skin structure | 7 days following assessment of skin function/responsiveness (to allow the hyperaemic response to subside), a single 3mm skin punch biopsy will be taken from the non-dominant forearm. The sample will be processed and stained to highlight blood vessels and endothelia, as well as sweat glands. The samples will be stained with fluorescein-labelled ulex europaeus, an endothelium-specific antibody and with protein gene product 9.5, a sweat gland antibody. Confocal microscopic imaging of the samples will be analysed to quantify the number and size of stained blood vessels and the number and size of the sweat glands. | Baseline (visit 2) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04553029 -
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
|
||
Completed |
NCT03672513 -
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
|
N/A | |
Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
Completed |
NCT05617287 -
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
|
N/A | |
Recruiting |
NCT05180266 -
Therapeutic Touch and Music in The Menopausal Period
|
N/A | |
Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
Completed |
NCT03363997 -
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
|
Phase 1 | |
Not yet recruiting |
NCT04724135 -
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
|
||
Not yet recruiting |
NCT04728126 -
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
|
||
Completed |
NCT02274571 -
Raising Insulin Sensitivity in Post Menopause
|
Early Phase 1 | |
Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
Recruiting |
NCT01488903 -
A Cohort Research of Genetic Susceptibility for Common Obesity in Women
|
N/A | |
Terminated |
NCT01633814 -
Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women
|
N/A | |
Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A |