Actively Recruiting
Influences of Long-acting Reversible Contraceptives on Iron Status and Physiological Responses to Extreme Environments in Women
Led by United States Army Research Institute of Environmental Medicine · Updated on 2026-04-30
33
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Over recent years, military service women have shown increasing interest in utilizing long-acting reversible contraceptives (LARCs; i.e., implants or intrauterine devices, IUDs). While clinically, LARC have been proven safe and effective at preventing pregnancy \& decreasing menstrual symptoms, it is unclear what impact this type of contraceptive may have on physiological responses to extreme environments (heat, cold and high altitude). Additionally, iron deficiency and iron deficiency anemia are prevalent in U.S. military women which likely affect health and performance. There is evidence to suggest that the prevalence of iron deficiency and iron deficiency anemia is lower in women utilizing LARCs, which preserve iron stores, likely due to reduced menstrual blood loss that compounds with each cycle over the course of months. Due to the increasing interest in the utilization of LARCs it is important to understand what, if any, impact these methods of contraception may have on a female Soldier's physiological responses. The overall goal of the present study is to characterize iron status and physiological responses (including but not limited to sweating, skin blood flow, ventilation, and heart rate) to extreme environmental stressors of heat, cold and high altitude (i.e. hypobaric hypoxia) in women utilizing LARCs. Up to thirty-three individuals (n=18 LARCs, n=15 monophasic oral contraceptives) will complete testing visits separated by at least 48 hours for environmental testing visits. During heat stress testing, measures of core body temperature, skin temperature, and sweat rate will be measured during a standardized protocol in hot, humid conditions. During cold stress, measures of body core temperature, metabolic heat production, skin blood flow and temperature (at both distal extremity and proximal body sites) will be assessed in order to better quantify the impact of exogenous sex hormones via LARCs and OCs in volunteers exposed to the cold. Measurements will be obtained during a standardized protocol in cold air (\~90 min; 10°C). For altitude, cardiopulmonary responses will be assessed during rest and exercise during an acute altitude exposure (4300m). Blood samples will be collected throughout the investigation in order to quantify sex hormone concentrations, iron status, and inflammatory biomarkers in response to environmental stressors. The investigators will also utilize laboratory tests (i.e., carbon monoxide (CO) rebreathing technique) and collect blood samples to quantity iron stores in these groups of women. To characterize iron status, the Soldier Performance Health and Readiness (SPHERE) epidemiological data repository will be utilized to quantify the prevalence of iron deficiency and iron deficient anemia diagnoses between women using LARCs and women not utilizing LARCs.
CONDITIONS
Official Title
Influences of Long-acting Reversible Contraceptives on Iron Status and Physiological Responses to Extreme Environments in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18 to 40 years
- Using monophasic oral contraceptives or implantable contraception (IUD, implant) for at least one year and at least one year since removal if applicable
- In good health as determined by Office of Medical Support and Oversight (OMSO)
- Passed most recent Army Combat Fitness Test (military) or exercises at least twice weekly (civilian)
- Willing to avoid alcohol 24 hours before testing
- Willing to avoid caffeine 12 hours before testing
- Willing to avoid moderate to strenuous exercise 24 hours before testing
- Willing to stay and exercise in an altitude chamber for about 6 hours
- Has supervisor approval if a federal civilian employee or non-HRV active-duty military stationed at NSSC
You will not qualify if you...
- Pregnant, planning pregnancy, or breastfeeding
- Taking medications or supplements other than contraceptives unless approved by OMSO and Principal Investigator
- Tobacco or nicotine use within last four months
- Physical injuries or conditions affecting treadmill walking or running
- Allergy to skin adhesive
- Heart, lung, kidney, muscle, endocrine, or nerve disorders as determined by OMSO
- History of heat intolerance or orthostatic intolerance
- Diagnosed or treated for fluid/electrolyte imbalance in last 30 days
- History of gastrointestinal obstructive diseases
- Scheduled MRI within 2 weeks after heat or cold test
- Actively dieting to lose weight
- History of cold injuries or Raynaud's syndrome
- Cold-induced asthma or bronchospasm
- Unwilling to have small skin areas shaved if needed
- Born at altitudes above 2100 m or living/traveling above 1200 m recently
- Prior diagnosis of High Altitude Pulmonary or Cerebral Edema
- Abnormal blood counts or presence of sickle cell trait
- History of pneumothorax or hypertension
- Blood donation within 8 weeks before study
- Recent or upcoming immobility or limited activity
- Evidence of sleep disorders such as apnea, narcolepsy, or insomnia
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Trial Site Locations
Total: 1 location
1
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760
Actively Recruiting
Research Team
G
Gabrielle E Giersch, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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