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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: Completed Phase 1 study, sponsored by Population Council.

NCT00812630 is a Phase 1 study that has completed, run by Population Council. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 68 participants
Start Date 2008-12
Est. Completion 2014-03
Phase Phase 1
Population Council

11 total trials

What the finished NCT00812630 record still lists

NCT00812630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).

The record links to 0 conditions, and to 1 intervention - of which MENT or placebo is the first listed.

NCT00812630 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00812630's enrollment target sits among peer trials

68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00812630, the US trial registry maintained by the National Library of Medicine. NCT00812630 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.