NCT06499727

HighCycle Study: 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

Millions of people travel to high altitude for work or leisure activities and are exposed to reduced inspiratory oxygen partial pressure and hypoxemia that may lead to altitude illness, among which the most common form is acute mountain sickness (AMS). The main AMS symptoms are headache, malaise, weakness, and fatigue. Prospective studies have shown that 20-60% of newcomers at 2500-4000m develop AMS requiring them to take medications, while, at very high altitudes, AMS may progress to high altitude cerebral oedema. Whether women are more susceptible to AMS remains insufficiently understood since no prospective study controlled for sex hormones, use of hormone contraception or assessed menstrual cycle phase (MCP) at altitude. Therefore, women remain underrepresented and poorly characterized in high altitude studies. In addition, the efficacy and safety of 250 mg/day acetazolamide, the standard recommendation for AMS prevention, has never been compared between sexes, although, women have presumably higher acetazolamide plasma concentration due to lower blood volume. Given the known dose-dependent preventive but also side effects of acetazolamide and equal proportion of women and men among mountain travellers, there is an urgent need to conclusively quantify the efficacy and safety of pre-ventive acetazolamide therapy against AMS in women compared to men.

Conditions

• Acute Mountain Sickness

Interventions

Type	Name	Description
DRUG	Acetazolamide	Administration of 1x125mg acetazolamide in the morning, 1x125mg in the evening, starting 24 hours before departure to 3600 m.
DRUG	Placebo	Administration of equally looking placebo capsules in the morning and in the evening, starting 24 hours before departure to 3600 m.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2024-07-12
• Last updated: 2026-01-23

Locations

1 site across 1 country: Kyrgyzstan