MenopauseNCT06222073
Getting Under the Skin of the Menopausal Hot Flush
An observational study of Menopause, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Observational
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
Kirsty A. Roberts, PhD, 07780876255, k.a.roberts@ljmu.ac.uk
David A Low, PhD, 01519046244, d.a.low@ljmu.ac.uk
About this study
Official title: The Menopausal Hot Flush: Cutaneous Vascular and Sudomotor Function and Structure in Symptomatic Women
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.
Read the detailed description
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.
- Conditions
- Menopause
- Keywords
- hot flush, skin, blood flow, sweating, structure, function
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal + Hot Flush (P+HF) | Postmenopausal women who regularly experience hot flushes. | |
| Postmenopausal + Hot Flush (P-HF) | Postmenopausal women who do not experience hot flushes. | |
| Premenopausal | Premenopausal women who experience regular menstruation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (visit 1)
Oestradiol
A venous blood sample will be taken and analysed to establish the oestradiol level (pg/mL).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Kirsty A. Roberts, PhD, Principal investigator, Liverpool John Moores UniversityDavid A Low, PhD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222073
- Sponsor's protocol ID
- MenoSkin
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roberts KA, Doyle A, Jones H, Low DA. Getting under the skin of the menopausal hot flush: a protocol to examine skin function and structure in symptomatic postmenopausal women. Front Glob Womens Health. 2025 Aug 4;6:1514960. doi: 10.3389/fgwh.2025.1514960. eCollection 2025.
PubMed 40832439
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Menopausal Hot Flush: Cutaneous Vascular and Sudomotor Function and Structure in Symptomatic Women
- ClinicalTrials.gov ID
- NCT06222073
- Acronym / sponsor ID
- MenoSkin
- Conditions
- Menopause
- Keywords
- hot flush, skin, blood flow, sweating, structure, function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal + Hot Flush (P+HF) | – | –Postmenopausal women who regularly experience hot flushes. |
| Postmenopausal + Hot Flush (P-HF) | – | –Postmenopausal women who do not experience hot flushes. |
| Premenopausal | – | –Premenopausal women who experience regular menstruation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin function/responsiveness
Time frame: Baseline (visit 1)
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.
Sweat gland function/responsiveness
Time frame: Baseline (visit 1)
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.
Oestradiol
Time frame: Baseline (visit 1)
A venous blood sample will be taken and analysed to establish the oestradiol level (pg/mL).
Interleukin-6 (IL-6)
Time frame: Baseline (visit 1)
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.
Interleukin-8 (IL-8)
Time frame: Baseline (visit 1)
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.
Tumour Necrosis Factor alpha (TNF-α)
Time frame: Baseline (visit 1)
A venous blood sample will be taken to assess circulating inflammatory markers/cytokines. TNF-α will be measured (pg/mL) using an ELISA.
Prostaglandin E2
Time frame: Baseline (visit 1)
A venous blood sample will be taken to assess circulating inflammatory markers/cytokines. Prostaglandin E2 will be measured (pg/mL) using an ELISA.
C-reactive Protein (CRP)
Time frame: Baseline (visit 1)
A venous blood sample will be taken to assess circulating inflammatory markers/cytokines. CRP will be measured (mg/L) using an ELISA.
Calcitonin Gene Related Peptide (CGRP)
Time frame: Baseline (visit 1)
A venous blood sample will be taken to assess circulating inflammatory markers/cytokines. CGRP will be measured (pg/mL) using an ELISA.
Skin structure (blood vessels)
Time frame: Baseline (visit 2)
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.
Skin structure (sweat glands)
Time frame: Baseline (visit 2)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 40832439Roberts KA, Doyle A, Jones H, Low DA. Getting under the skin of the menopausal hot flush: a protocol to examine skin function and structure in symptomatic postmenopausal women. Front Glob Womens Health. 2025 Aug 4;6:1514960. doi: 10.3389/fgwh.2025.1514960. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty A. Roberts, PhD principal investigator
Liverpool John Moores University
David A Low, PhD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Liverpool John Moores University at 1 site in United Kingdom.
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 12 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Mar 2025. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsty A. Roberts, PhD (0151 904 6244, k.a.roberts@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin function/responsiveness (time frame: Baseline (visit 1)). The study lists 11 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 NCT06222073, which also lists 1 linked publication.
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 18 Mar 2025.