Understanding menopausal hot flushes
The Menopausal Hot Flush: Cutaneous Vascular and Sudomotor Function and Structure in Symptomatic Women
Liverpool John Moores University · NCT06222073
This study is testing how blood vessels and sweat glands work in women who have hot flushes to help find better treatments for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Liverpool John Moores University (other) |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT06222073 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate how skin blood vessels and sweat glands function in women experiencing hot flushes. Participants will attend two laboratory visits where they will undergo various assessments, including hormone level testing and skin microdialysis to evaluate blood flow and sweating responses. Additionally, a small skin biopsy will be taken to examine the structure of these skin components. The findings could enhance our understanding of the mechanisms behind hot flushes and inform the development of effective treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged over 45 who experience more than four hot flushes per day and are amenorrhoeic for over six months.
Not a fit: Patients who are male, aged under 18 or between 31-44, or those currently taking medications for hot flushes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for menopausal hot flushes, enhancing the quality of life for affected women.
How similar studies have performed: While there have been studies on menopausal symptoms, this specific approach using skin microdialysis and biopsies to understand hot flushes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Liverpool, Merseyside
- Liverpool John Moores University — Liverpool, Merseyside, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Kirsty A. Roberts, PhD — Liverpool John Moores University
- Study coordinator: Kirsty A. Roberts, PhD
- Email: k.a.roberts@ljmu.ac.uk
- Phone: 0151 904 6244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menopause, hot flush, skin, blood flow, sweating, structure, function