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DEA for Hormones

N/A
Waitlist Available
Led By Janet E Hall, M.D.
Research Sponsored by National Institute of Environmental Health Sciences (NIEHS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up nea intervention day 5 and dea intervention day 5
Awards & highlights

Study Summary

This trial studies how diet, exercise, and other factors influence women's menstrual cycles in those with functional hypothalamic amenorrhea. Healthy women ages 18-28 with regular periods will be screened and have 9-10 visits over 3 menstrual cycles. They'll keep logs and take tests and supplements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~nea intervention day 5 and dea intervention day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and nea intervention day 5 and dea intervention day 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measure will be change in daytime LH pulse frequency following 5 days of neutral energy availability as compared to LH pulse frequency following 5 days deficient energy availability. LH pulse frequency.
Secondary outcome measures
Change in cortisol, TSH, TT3, and fT4
Change in hormone measures (LH, FSH, estradiol, and progesterone) from daily urine samples and blood spots, total cycle, follicular and luteal phase length during the cycle following NEA or DEA
Change in leptin, ghrelin, adiponectin, insulin, and glucose in response to standardized breakfast, lunch, and snack

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
All participants will be in the experimental arm and receive the DEA intervention.
Group II: ControlActive Control1 Intervention
All participants will receive the NEA availability to act as their own control to the experimental DEA intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DEA
2017
N/A
~40

Find a Location

Who is running the clinical trial?

National Institute of Environmental Health Sciences (NIEHS)Lead Sponsor
284 Previous Clinical Trials
1,232,699 Total Patients Enrolled
2 Trials studying Hormones
157 Patients Enrolled for Hormones
Janet E Hall, M.D.Principal InvestigatorNational Institute of Environmental Health Sciences (NIEHS)
10 Previous Clinical Trials
26,693 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)
2017. "CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02858336.
~5 spots leftby Apr 2025
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