Search / Trial NCT06222073

Getting Under the Skin of the Menopausal Hot Flush

Launched by LIVERPOOL JOHN MOORES UNIVERSITY · Jan 23, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Hot Flush Skin Blood Flow Sweating Structure Function

ClinConnect Summary

This clinical trial, titled "Getting Under the Skin of the Menopausal Hot Flush," is investigating how the blood vessels and sweat glands in the skin work in women who experience hot flushes during menopause. Researchers will use a special technique to deliver small amounts of substances to the skin, which will help them understand how blood flow and sweating are affected. They will also take a tiny sample of skin to look at the structure of these blood vessels and sweat glands. By learning more about what happens in the skin during hot flushes, the study aims to find better treatments for this common menopausal symptom.

To be eligible for this trial, women must be between 45 and 74 years old and experiencing more than four hot flushes a day, or they can be aged 18 to 30 and have regular menstrual cycles. Participants need to be healthy, non-smokers, and meet certain weight criteria. Those selected for the study can expect to undergo some simple tests and a small skin biopsy, which is a quick procedure to collect a sample of skin. It's important to note that women who are pregnant, smokers, or have certain medical conditions will not be able to join the study.

Gender

FEMALE

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

Trial Officials

Kirsty A. Roberts, PhD

Principal Investigator

Liverpool John Moores University

David A Low, PhD

Principal Investigator

Liverpool John Moores University

About Liverpool John Moores University

Liverpool John Moores University (LJMU) is a leading research institution in the UK, renowned for its commitment to advancing knowledge and innovation across various fields, including health and clinical sciences. With a robust infrastructure for clinical research, LJMU collaborates with healthcare professionals, industry partners, and community organizations to conduct rigorous clinical trials aimed at improving patient outcomes. The university emphasizes ethical research practices and strives to translate findings into real-world applications, fostering an environment that supports both scientific inquiry and the development of future healthcare solutions. Through its dedicated research teams and state-of-the-art facilities, LJMU continues to play a pivotal role in shaping the landscape of clinical research and education.

Locations

Liverpool, Merseyside, United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0