Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499727
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
HighCycle Study Effect of Acetazolamide on Acute Mountain Sickness in Women Compared to Men
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
HighCycle Study Effect of Acetazolamide on Acute Mountain Sickness in Women Compared to Men A Randomized Placebo-Controlled Double-Blind Parallel Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None