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NCT03740204 · ClinicalTrials.gov registry record · Phase 2
The Role of Estrogen in the Neurobiology of Eating Disorders
A Phase 2 study of Eating Disorders and Hypoestrogenemia, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03740204: Recruiting Phase 2 study of Eating Disorders and Hypoestrogenemia, sponsored by Massachusetts General Hospital.
NCT03740204 is a Phase 2 study of Eating Disorders and Hypoestrogenemia that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 120 participants, below the 319-participant average among 37 other Eating Disorders trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03740204, a Phase 2 study of Eating Disorders and Hypoestrogenemia, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.
Conditions Studied
Interventions
- DRUG 17-β estradiol transdermal patches with cyclic progesterone
- DRUG Placebo patch and pill
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03740204
The ClinicalTrials.gov registry entry for NCT03740204 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 37 other Eating Disorders trials with a reported enrollment target (62% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Eating Disorders appearing as the primary indexed condition, and to 2 interventions - of which 17-β estradiol transdermal patches with cyclic progesterone is the first listed.
NCT03740204 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03740204 about?
NCT03740204 is a clinical study titled "The Role of Estrogen in the Neurobiology of Eating Disorders". This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characteri...
What is the current status of trial NCT03740204?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-06-13. Estimated completion is 2026-12-31.
What conditions does trial NCT03740204 study?
This clinical trial studies the following conditions: Eating Disorders, Hypoestrogenemia.
What interventions are being tested in trial NCT03740204?
The interventions under investigation include: 17-β estradiol transdermal patches with cyclic progesterone (DRUG), Placebo patch and pill (DRUG).
Who is sponsoring clinical trial NCT03740204?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03740204 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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