Energy Deficiency on Hormones in Contraceptive Users
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Energy Deficiency of approximately ~250 kcal/day
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov