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Recruiting NCT06222073

Getting Under the Skin of the Menopausal Hot Flush

— Observational Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Menopause. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Menopausal Hot Flush: Cutaneous Vascular and Sudomotor Function and Structure in Symptomatic Women

Overview

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.

Primary outcome measures

  • Skin function/responsiveness [Time frame: Baseline (visit 1)]
  • Sweat gland function/responsiveness [Time frame: Baseline (visit 1)]
  • Oestradiol [Time frame: Baseline (visit 1)]
  • Interleukin-6 (IL-6) [Time frame: Baseline (visit 1)]
  • Interleukin-8 (IL-8) [Time frame: Baseline (visit 1)]
  • Tumour Necrosis Factor alpha (TNF-α) [Time frame: Baseline (visit 1)]
  • Prostaglandin E2 [Time frame: Baseline (visit 1)]
  • C-reactive Protein (CRP) [Time frame: Baseline (visit 1)]
  • Calcitonin Gene Related Peptide (CGRP) [Time frame: Baseline (visit 1)]
  • Skin structure (blood vessels) [Time frame: Baseline (visit 2)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United Kingdom · 1 center
  • Liverpool John Moores University — Liverpool

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. PMID 40832439

Identifiers

NCT: NCT06222073 · MenoSkin

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗