Low Energy Availability and Pituitary Function (LEAP Study) (NCT05808647) | Clinical Trial Compass
UnknownNot Applicable
Low Energy Availability and Pituitary Function (LEAP Study)
United States25 participantsStarted 2023-04
Plain-language summary
The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.
Who can participate
Age range
18 Years – 30 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female
* Age 18-30
* Body mass index between 18.5-24.9 OR 30-45
* Have regular menstrual cycles between 18-40 days over the past 6 months
* Weight stable (not gained or lost 5kg) in the past 3 months
Exclusion Criteria:
* Using hormonal birth control currently or within the past three months
* Polycystic ovary syndrome (current or past diagnosis)
* Pregnant, lactating, planning to become pregnant in next 6 months
* Engaging in regular intentional aerobic exercise
* Significant medical issues (e.g.,cardiovascular disease or diabetes)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate
Timeframe: Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)