HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-12-31

Brief Summary

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Prospective cohort study investigating the menstrual cycle phase (MCP)-dependent incidence of acute mountain sickness (AMS) in women travelling to 3600 m.

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Detailed Description

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Conditions

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Acute Mountain Sickness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women in luteal MCP

Women being in their luteal MCP on the day of ascent to high altitude.

Exposure to 3600 m

Intervention Type OTHER

Participants will travel to and stay for 2 days at an altitude of 3600 m.

Women in follicular MCP

Women being in their follicular MCP on the day of ascent to high altitude.

Exposure to 3600 m

Intervention Type OTHER

Participants will travel to and stay for 2 days at an altitude of 3600 m.

Interventions

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Exposure to 3600 m

Participants will travel to and stay for 2 days at an altitude of 3600 m.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy, non-smoking 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, eumenorrheic cycle

Exclusion Criteria

* Other types of 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes