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NCT01116401 · ClinicalTrials.gov registry record · Phase 4
Impact of Hot Flashes on Sleep and Mood Disturbance
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT01116401: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01116401 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116401, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
Interventions
- DRUG leuprolide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-11-03 |
| Est. Completion | 2012-01-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01116401
The ClinicalTrials.gov registry entry for NCT01116401 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which leuprolide is the first listed.
NCT01116401 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01116401 about?
NCT01116401 is a clinical study titled "Impact of Hot Flashes on Sleep and Mood Disturbance". We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition....
What is the current status of trial NCT01116401?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2009-11-03. Estimated completion is 2012-01-04.
What interventions are being tested in trial NCT01116401?
The interventions under investigation include: leuprolide (DRUG).
Who is sponsoring clinical trial NCT01116401?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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