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NCT06909695 · ClinicalTrials.gov registry record

Influences of Long-acting Reversible Contraceptives on Iron Status and Physiological Responses to Extreme Environments in Women

A clinical trial of Contraception and Iron Deficiencies, sponsored by United States Army Research Institute of Environmental Medicine.

Recruiting
Registry status
33
Enrollment target
1
Study location

NCT06909695 is a study of Contraception and Iron Deficiencies that is actively recruiting participants, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 33 participants, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06909695, a study of Contraception and Iron Deficiencies, is actively recruiting participants, sponsored by United States Army Research Institute of Environmental Medicine.

RECRUITING
Registry status
33 participants
Enrollment target
1
Study location

Study Summary

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

Interventions

  • OTHER Blood volume and environmental testing

Study Locations (1)

Massachusetts

  • US Army Research Institute of Environmental Medicine - Natick

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2024-11-01
Est. Completion 2027-09

What the Registry Record Tells You About NCT06909695

The ClinicalTrials.gov registry entry for NCT06909695 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (93% lower). The listed sponsor is United States Army Research Institute of Environmental Medicine, which has 59 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Blood volume and environmental testing is the first listed.

NCT06909695 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06909695 about?

NCT06909695 is a clinical study titled "Influences of Long-acting Reversible Contraceptives on Iron Status and Physiological Responses to Extreme Environments in Women". 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 i...

What is the current status of trial NCT06909695?

This trial is currently recruiting. The enrollment target is 33 participants. The study started on 2024-11-01. Estimated completion is 2027-09.

What conditions does trial NCT06909695 study?

This clinical trial studies the following conditions: Contraception, Iron Deficiencies.

What interventions are being tested in trial NCT06909695?

The interventions under investigation include: Blood volume and environmental testing (OTHER).

Who is sponsoring clinical trial NCT06909695?

This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06909695 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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