An observational study in Menopause, sponsored by Liverpool John Moores University. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Liverpool John Moores University · Observational
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.
In a cross-sectional design, participants will attend the laboratory on two separate occasions. At visit 1, anthropometric measurements will be recorded and a venous blood sample will be collected to determine hormone status (e.g. oestradiol level) and pro-inflammatory markers (e.g. IL-8, Prostaglandin 2E). Participants will then undergo assessment of post-ganglionic skin blood vessel and sweat gland responsiveness (transdermal/cutaneous microdialysis). At visit 2 (\~7 days later), participants will undergo a skin punch biopsy.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 36 is below the median of 97 across 18 observational studies indexed under Hot Flashes.
Browse Hot Flashes studies →Liverpool John Moores University is the lead sponsor of 75 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
24 postmenopausal women (12 who experience hot flushes and 12 who do not) and 12 premenopausal women will be recruited for this study.
Postmenopausal participants (aged >45 years) will be required to be amenorrhoeic for at least six months and symptomatic women should be experiencing at least four hot flushes per day. Premenopausal women will be eumenorrhoeic and will be aged 18-30 yrs. Participants will be healthy and free from cardiovascular and metabolic risk factors or diseases, and not taking any treatments to alleviate hot flushes. Participants will be required to complete a health screening questionnaire to confirm they are eligible to participate in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal women who regularly experience hot flushes.
Postmenopausal women who do not experience hot flushes.
Premenopausal women who experience regular menstruation.
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.
Time frame: Baseline (visit 1)
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.
Time frame: Baseline (visit 1)
Oestradiol
A venous blood sample will be taken and analysed to establish the oestradiol level (pg/mL).
Time frame: Baseline (visit 1)
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.
Time frame: Baseline (visit 1)
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.
Time frame: Baseline (visit 1)
Tumour Necrosis Factor alpha (TNF-α)
A venous blood sample will be taken to assess circulating inflammatory markers/cytokines. TNF-α will be measured (pg/mL) using an ELISA.
Time frame: Baseline (visit 1)
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.
Time frame: Baseline (visit 1)
C-reactive Protein (CRP)
A venous blood sample will be taken to assess circulating inflammatory markers/cytokines. CRP will be measured (mg/L) using an ELISA.
Time frame: Baseline (visit 1)
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.
Time frame: Baseline (visit 1)
Skin structure (blood vessels)
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. The samples will be stained with fluorescein-labelled ulex europaeus, an endothelium-specific antibody. Confocal microscopic imaging of the samples will be analysed to quantify capillary density e.g. capillary count/length of the epidermal surface (capillaries/mm) and capillary diameter.
Time frame: Baseline (visit 2)
Skin structure (sweat glands)
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 sweat glands. The samples will be stained with protein gene product 9.5, a sweat gland/nerve fibre antibody. Confocal microscopic imaging of the samples will be analysed to quantify sweat gland density.
Time frame: Baseline (visit 2)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Oct 2025, 33 months after the start.
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Liverpool John Moores University