- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06222073
Getting Under the Skin of the Menopausal Hot Flush
The Menopausal Hot Flush: Cutaneous Vascular and Sudomotor Function and Structure in Symptomatic Women
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kirsty A. Roberts, PhD
- Phone Number: 0151 904 6244
- Email: k.a.roberts@ljmu.ac.uk
Study Contact Backup
- Name: David A Low, PhD
- Phone Number: 0151 904 6244
- Email: d.a.low@ljmu.ac.uk
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L3 3AF
- Recruiting
- Liverpool John Moores University
-
Contact:
- Kirsty A. Roberts, PhD
- Phone Number: 07780876255
- Email: k.a.roberts@ljmu.ac.uk
-
Contact:
- David A Low, PhD
- Phone Number: 01519046244
- Email: d.a.low@ljmu.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (visit 1)
|
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.
|
Baseline (visit 1)
|
Oestradiol
Time Frame: Baseline (visit 1)
|
A venous blood sample will be taken and analysed to establish the oestradiol level (pg/mL).
|
Baseline (visit 1)
|
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. |
Baseline (visit 1)
|
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. |
Baseline (visit 1)
|
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 (IL-8) will be measured (pg/mL) using an ELISA. |
Baseline (visit 1)
|
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. |
Baseline (visit 1)
|
C-reactive Protein (CRP)
Time Frame: Baseline (visit 1)
|
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)
|
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. |
Baseline (visit 1)
|
Skin structure
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, 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirsty A. Roberts, PhD, Liverpool John Moores University
- Principal Investigator: David A Low, PhD, Liverpool John Moores University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MenoSkin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Menopause
-
Riphah International UniversityCompleted
-
Englewood Hospital and Medical CenterNanohealth, Inc.WithdrawnMenopause SymptomsUnited States
-
Englewood Hospital and Medical CenterNanohealth, Inc.CompletedMenopause SymptomsUnited States
-
University of Colorado, DenverCompletedMenopause | Pre-menopauseUnited States
-
S.LAB (SOLOWAYS)Center of New Medical TechnologiesCompletedMenopause SymptomsRussian Federation
-
BHR Pharma, LLCTerminatedMenopause Related ConditionsGermany
-
Singapore General HospitalRecruitingMenopause | Menopause Related ConditionsSingapore
-
University of ArkansasRecruitingMenopause Related ConditionsUnited States
-
Wake Forest University Health SciencesWithdrawnMenopause Related Conditions
-
I.M. Sechenov First Moscow State Medical UniversityCompletedMenopause Related ConditionsRussian Federation