Effect of Acetazolamide on Acute Mountain Sickness in Women Compared to Men
HighCycle Study: Effect of Acetazolamide on Acute Mountain Sickness in Women Compared to Men: A Randomized, Placebo-Controlled, Double-Blind Parallel Trial
This study tests if acetazolamide can help prevent acute mountain sickness in women compared to men when they are exposed to high altitudes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Bishkek) |
| Trial ID | NCT06499727 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of acetazolamide in preventing acute mountain sickness (AMS) among healthy men and women, with a specific focus on the differences between sexes. It aims to address the underrepresentation of women in altitude studies by controlling for factors such as sex hormones and menstrual cycle phases. Participants will be given either acetazolamide or a placebo while exposed to high altitudes, and their symptoms of AMS will be monitored. The study seeks to provide a clearer understanding of how gender influences susceptibility to AMS and the efficacy of preventive treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy, non-smoking men and women aged 18-44 who live at low altitudes and are premenopausal with regular menstrual cycles.
Not a fit: Patients who are pregnant, nursing, or using certain forms of hormonal contraception may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for acute mountain sickness, particularly for women.
How similar studies have performed: While studies on acute mountain sickness exist, this specific focus on gender differences and hormonal influences is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy, non-smoking men and women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives). * BMI \>18 kg/m2 and \<30 kg/m2 * Born, raised and currently living at altitudes \<1000 m * Written informed consent * Premenopausal women with an eumenorrheic cycle Exclusion Criteria: * Other types of contraceptvies (contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others) * Pregnancy or nursing * Anaemic (haemoglobin concentration \<10g/dl) * Any altitude trip \<4 weks before the study * Allergy to acetazolamide and other sulfonamides
Where this trial is running
Bishkek
- National Center for Cardiology and Internal Medicine — Bishkek, Kyrgyzstan (Recruiting)
Study contacts
- Study coordinator: Michael Furian, Prof. Dr.
- Email: michael.furian@usz.ch
- Phone: +41794037586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.