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 October 08, 2024

Recruiting

Keywords

Hot Flush Skin Blood Flow Sweating Structure Function

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.

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

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