Getting Under the Skin of the Menopausal Hot Flush

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 18 Years to 60 Years · Accepts healthy volunteers.

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

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2023-01-01
• Primary completion: 2025-10-31
• Last update posted: 2025-03-18
• First posted: 2024-01-24

Sponsor & contact

Lead sponsor: Liverpool John Moores University (Other)

Collaborators: British Heart Foundation

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Skin function/responsiveness (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…
• Sweat gland function/responsiveness (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…
• Oestradiol (Baseline (visit 1))
  A venous blood sample will be taken and analysed to establish the oestradiol level (pg/mL).
• Interleukin-6 (IL-6) (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) (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.

Related ClearedRx care

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