Energy Deficiency on Hormones in Contraceptive Users

Conditions

• Energy Deficiency Due to Short-term Fasting
• Hormonal Contraception

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 35 Years

Healthy Volunteers

Not accepted

Interventions

• Energy Deficiency of approximately ~250 kcal/day — BEHAVIORAL
  Following an initial baseline menstrual cycle, participants will be subjected to at least two weeks of a \~250 kcal/day energy deficit monitored through daily diet tracking.

Study Details

The purpose of the present study is to characterize the endocrine and metabolic responses to a modest, short-term energy deficiency (\~250 kcal/day) across the menstrual cycle in recreationally active women using different contraceptive methods (oral contraceptive, hormonal IUD, and non-hormonal IUD). This study will leverage daily urinary hormone metabolite tracking and comprehensive metabolic assessments, providing foundational data addressing an important and previously unexamined interaction between energy availability and hormonal regulation in contraceptive users.

Key Dates

Start date

Sep 30, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: Monophasic low dose oral contraceptive users
  The first group will be only individuals who are on a low dose, monophasic oral contraceptive that they have elected to be on prior to enrollment in the study. They will undergo a baseline monitoring menstrual cycle that will include daily urinary hormone monitoring, baseline metabolic and body composition assessments, and assessment of baseline energy expenditure and energy intake. During a two week washout week, participants will not be monitoring hormones, but will be subjected to a \~250 kcal/day energy deficit. Following this imposed energy deficiency, they will resume urinary metabolite testing and exercise intake and expenditure tracking. They will undergo this monitoring for a final menstrual cycle and metabolic and body composition assessments, and assessment of energy expenditure and energy intake.
• Experimental: Hormonal IUD
  The second group will be only individuals who have a hormonal IUD that they have elected to be on prior to enrollment in the study. They will undergo a baseline monitoring menstrual cycle that will include daily urinary hormone monitoring, baseline metabolic and body composition assessments, and assessment of baseline energy expenditure and energy intake. During a two week washout week, participants will not be monitoring hormones, but will be subjected to a \~250 kcal/day energy deficit. Following this imposed energy deficiency, they will resume urinary metabolite testing and exercise intake and expenditure tracking. They will undergo this monitoring for a final menstrual cycle and metabolic and body composition assessments, and assessment of energy expenditure and energy intake.
• Experimental: Non-Hormonal (i.e., Copper) IUD
  The last group will be only individuals who have a non-hormonal/copper IUD that they have elected to be on prior to enrollment in the study. They will undergo a baseline monitoring menstrual cycle that will include daily urinary hormone monitoring, baseline metabolic and body composition assessments, and assessment of baseline energy expenditure and energy intake. During a two week washout week, participants will not be monitoring hormones, but will be subjected to a \~250 kcal/day energy deficit. Following this imposed energy deficiency, they will resume urinary metabolite testing and exercise intake and expenditure tracking. They will undergo this monitoring for a final menstrual cycle and metabolic and body composition assessments, and assessment of energy expenditure and energy intake

Primary Outcome Measure

Urinary hormone exposure [ Time Frame: From enrollment to energy deficit menstrual cycle is 3 months/90 days ]

Central Contacts

• Emily Lundstrom, PhD
  3234422180
  [email protected]

Locations (1)

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