Energy Deficiency on Hormones in Contraceptive Users

NCT07651800 | Not Yet Recruiting

• 1 other identifier: HS-26-00204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Energy Deficiency Due to Short-term Fasting; Hormonal Contraception

Outcome Measures

Primary Outcomes (1)

• Urinary hormone exposure

  Participants will be asked to track daily urine concentrations of estrogen and progesterone throughout a baseline (i.e., non-energy-deficient state) menstrual cycle and a menstrual cycle with an imposed energy deficit. The outcome will compare hormone exposure measured by the urinary concentrations between the two cycles.

  From enrollment to energy deficit menstrual cycle is 3 months/90 days

Secondary Outcomes (5)

• Estimated versus actual resting metabolic rate

  From enrollment to completion 90 days/3 months

• Eating behaviors and attitudes will be measured using the EDEQ and the Three Factor Eating Questionnaire

  From enrollment to conclusion 90 days/3 months

• Subjective stress levels will measured using the Perceived Stress Scale

  From enrollment to conclusion 90 days/3 months

• Low Energy Availability Indicators will be assessed using the LEAF-Q

  From enrollment to conclusion 90 days/3 months

• Body composition will be measured using DXA

  From enrollment to conclusion 90 days/3 months

Study Arms (3)

Monophasic low dose oral contraceptive users

EXPERIMENTAL

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.

Behavioral: Energy Deficiency of approximately ~250 kcal/day

Hormonal IUD

EXPERIMENTAL

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.

Behavioral: Energy Deficiency of approximately ~250 kcal/day

Non-Hormonal (i.e., Copper) IUD

EXPERIMENTAL

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

Behavioral: Energy Deficiency of approximately ~250 kcal/day

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.

Hormonal IUD; Monophasic low dose oral contraceptive users; Non-Hormonal (i.e., Copper) IUD

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, aged 18-35 years
• Recreationally active (engaging in structured exercise between 8-15 hours per week)
• BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths17
• Not currently experiencing an eating disorder or disordered eating, or having a diagnosed eating disorder in the last 3 years
• Non-pregnant or planning to become pregnant
• Medically free from chronic diseases
• Currently using one of the following contraceptive methods for ≥3 months:
• Monophasic oral contraceptive
• Hormonal intrauterine device (H-IUD)
• Copper intrauterine device
• Weight stable (no weight change \>5% body weight within the past 3 months)
• Weight greater than or equal to 110 lbs
• Not suffering from known gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity
• Willing and able to maintain current exercise habits throughout the study
• Willing to follow study dietary guidance to achieve a \~250 kcal/day energy deficit during Cycle 2

You may not qualify if:

• Amenorrhea or oligomenorrhea
• Perimenopausal or menopausal
• Currently pregnant, planning pregnancy, or breastfeeding
• Use of hormonal contraception other than monophasic oral contraceptives or hormonal IUD (implant, nuvaring, etc.)
• Initiation or change of contraceptive method within the past 3 months
• Diagnosis of polycystic ovary syndrome (PCOS), endometriosis, hypothalamic amenorrhea, or other known reproductive endocrine disorder
• Current or history of eating disorder or clinically diagnosed disordered eating
• Current participation in intentional weight loss or weight gain program
• Use of medications known to affect metabolism or hormone levels (e.g., systemic corticosteroids, thyroid medications, insulin, GLP-1 agonists)
• Known metabolic, cardiovascular, renal, hepatic, or endocrine disease
• Musculoskeletal injury limiting exercise participation within the past 3 months
• Smoking or nicotine use
• Contraindications to DXA scanning (e.g., pregnancy, recent high-radiation diagnostic imaging exceeding institutional limits)
• Inability or unwillingness to comply with study procedures

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California Health Sciences Campus Center for Health Professions

Los Angeles, California, 90033, United States

Location

Central Study Contacts

Emily Lundstrom, PhD

CONTACT

3234422180; elundstr@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: There will be three groups: oral contraceptive users, hormonal IUD users, and non-hormonal IUD users that will all undergo the same protocol. The first cycle will involve a baseline assessment of urinary hormone metabolites. The second cycle will involve an imposed energy deficiency for at least 2 weeks will continuous hormone monitoring.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)