Getting Under the Skin of the Menopausal Hot Flush

L

Liverpool John Moores University

Status

Enrolling

Conditions

Menopause

Study type

Observational

Funder types

Other

Identifiers

NCT06222073
MenoSkin

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

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
  • 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 design

36 participants in 3 patient groups

Postmenopausal + Hot Flush (P+HF)
Description:
Postmenopausal women who regularly experience hot flushes.
Postmenopausal + Hot Flush (P-HF)
Description:
Postmenopausal women who do not experience hot flushes.
Premenopausal
Description:
Premenopausal women who experience regular menstruation.

Trial contacts and locations

1

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Central trial contact

David A Low, PhD; Kirsty A. Roberts, PhD

Data sourced from clinicaltrials.gov

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