At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 35 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 60 Years
- Who
- Female
- Number of participants
- 36
- Started
- 2023-01-01
- Last checked
- 2024-10
Plain English Summary
What is this study?
- • Testing a new treatment for menopause
- • Clinical study - 36 participants
- • 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
Who can take part?
- • Ages 18 Years to 60 Years
- • Diagnosed with menopause
- • Female only
Where?
- • Liverpool - Liverpool John Moores University
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 60 Years
- Who can join: Female only
What the study is looking for
- ✓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 (causing symptoms postmenopausal criteria)
- ✓Eumenorrhoeic with regular menstrual cycles (premenopausal criteria)
Who cannot take part
- ✗Aged \< 18 years or 31-44 years
- ✗Smokers
- ✗Medical history of cardiovascular/respiratory disease
- ✗Medical history of metabolic disease e.g. type II diabetes
- ✗Drink \>15 units of alcohol per week
See the full criteria
Where Is This Study? (1 UK site)
Liverpool John Moores University
Liverpool L3 3AF, United Kingdom
How to Get in Touch
Kirsty A. Roberts, PhD
Sponsor contactCONTACT
David A Low, PhD
Sponsor contactCONTACT