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NCT00812630 · ClinicalTrials.gov registry record · Phase 1
A Two-part Trial Assessing the Effects of 7α-methyl-19-nortestosterone (MENT) on Blood Pressure in Normal Men: an Open-label Pilot Study Followed by a Randomized, Double-blind, Placebo-controlled Study
A Phase 1 study, sponsored by Population Council.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT00812630 is a Phase 1 study that has completed, run by Population Council. The registered enrollment target is 68 participants.
The verdict
NCT00812630, a Phase 1 study, has completed, sponsored by Population Council.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
This is a two-part trial assessing the effects of MENT on blood pressure. The first part of the trial is an open-label pilot study to verify the MENT gel formulation delivers appropriate drug levels. Upon confirming MENT serum levels are within the required range, clinical trial material will be produced and labeled. Consequently, the second part of the trial, the main study, will proceed approximately two months after the conclusion of the pilot study. The main study, is a randomized, double-blind, placebo-controlled study.
Interventions
- DRUG MENT or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2008-12 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00812630
The ClinicalTrials.gov registry entry for NCT00812630 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Population Council, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MENT or placebo is the first listed.
NCT00812630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00812630 about?
NCT00812630 is a clinical study titled "A Two-part Trial Assessing the Effects of 7α-methyl-19-nortestosterone (MENT) on Blood Pressure in Normal Men: an Open-label Pilot Study Followed by a Randomized, Double-blind, Placebo-controlled Study". This is a two-part trial assessing the effects of MENT on blood pressure. The first part of the trial is an open-label pilot study to verify the MENT gel formulation delivers appropriate drug levels. Upon confirming MENT serum levels are within the required range, clinical trial material will be pro...
What is the current status of trial NCT00812630?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2008-12. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00812630?
The interventions under investigation include: MENT or placebo (DRUG).
Who is sponsoring clinical trial NCT00812630?
This trial is sponsored by Population Council, which has 11 total clinical trials registered on ClinicalTrials.gov.
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