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NCT02858336 · ClinicalTrials.gov registry record · NA
CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)
A NA study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT02858336: Completed NA study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT02858336 is a NA study that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02858336, a NA study, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
Background: Functional hypothalamic amenorrhea (functional HA) is a condition where a woman s period stops for a temporary time. This is due to improper function of the hypothalamus. This is the part of the brain that directs the whole reproductive system. Researchers want to learn more about functional HA. They also want to learn how diet, exercise, and other factors may change women s menstrual cycles. Objective: To better understand functional HA. Eligibility: Healthy women ages 18-28 years old who: * Have regular periods * Exercise no more than 4 hours a week * Had their first period at age 11-14 Design: Participants will be prescreened over the phone. Participants will be screened with: * Blood and urine tests * Medical history * Physical exam. Participants will have 9 or 10 visits over about 3 menstrual cycles. These include: * Repeat of screening tests * Questionnaires * Exercise test * Resting energy expenditure test: Participants fast overnight before the test. They lie on their back under a canopy for a half hour. * Body composition test: This is done with a dual energy x-ray absorptiometry (DXA) scan. * Pelvic ultrasound * For two full-day visits, an IV is inserted into an arm vein. The IV takes a blood sample every 10 minutes for 8 hours. Participants will keep logs: * Menstrual cycle log * Diet log for three 4-day cycles Participants will receive test kits to complete at home: * Daily blood and urine sample * Ovulation Participants will take a daily iron supplement. They will wear a wristband that monitors activity 24 hours a day. Participants will stick to a special diet for two 5-day periods of time. They will complete two 4-day exercise programs....
Primary Outcome
Change in LH pulse frequency collected by sampling every 10 minutes over 8 hours during a study visit.
Interventions
- BEHAVIORAL NEA
- BEHAVIORAL DEA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-01-12 |
| Est. Completion | 2019-06-29 |
| Phase | NA |
What the finished NCT02858336 record still lists
NCT02858336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which NEA is the first listed.
NCT02858336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02858336 about?
NCT02858336 is a clinical study titled "CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)". Background: Functional hypothalamic amenorrhea (functional HA) is a condition where a woman s period stops for a temporary time. This is due to improper function of the hypothalamus. This is the part of the brain that directs the whole reproductive system. Researchers want to learn more about funct...
What is the current status of trial NCT02858336?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2017-01-12. Estimated completion is 2019-06-29.
What interventions are being tested in trial NCT02858336?
The interventions under investigation include: NEA (BEHAVIORAL), DEA (BEHAVIORAL).
Who is sponsoring clinical trial NCT02858336?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02858336's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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