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NCT01268046 · ClinicalTrials.gov registry record · Phase 1

Aging and Estrogen on Cortical Function

A Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target

NCT01268046: Completed Phase 1 study, sponsored by Massachusetts General Hospital.

NCT01268046 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01268046, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target

Study Summary

This study will focus on how estrogen affects parts of the brain associated with memory and how the effect of estrogen is altered with aging in postmenopausal women.

Primary Outcome

Change in extracted beta coefficients of the blood oxygen level dependent (BOLD) signal response to a cognitive task (N-back) in the DLPFC (x,y,z coordinates = -34 44 16) from baseline to 1 month as a function of aging and estrogen (young vs older and estrogen vs placebo). A positive change indicates an increase in oxygen utilization (inferring increased neuronal functioning) between baseline and treatment during the cognitive task, while a negative change indicates a decrease in oxygen utilizat

Interventions

  • DRUG Estradiol oral capsule
  • DRUG transderman estrogen patch
  • DRUG trasdermal placebo patch
  • DRUG placebo oral capsule

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2009-11
Est. Completion 2013-12-02
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT01268046 record still lists

NCT01268046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 4 interventions - of which Estradiol oral capsule is the first listed.

NCT01268046 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01268046 about?

NCT01268046 is a clinical study titled "Aging and Estrogen on Cortical Function". This study will focus on how estrogen affects parts of the brain associated with memory and how the effect of estrogen is altered with aging in postmenopausal women.

What is the current status of trial NCT01268046?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2009-11. Estimated completion is 2013-12-02.

What interventions are being tested in trial NCT01268046?

The interventions under investigation include: Estradiol oral capsule (DRUG), transderman estrogen patch (DRUG), trasdermal placebo patch (DRUG), placebo oral capsule (DRUG).

Who is sponsoring clinical trial NCT01268046?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01268046's enrollment target sits among peer trials

38 1197th of 2000 higher than 797 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 NCT01268046, the US trial registry maintained by the National Library of Medicine. NCT01268046 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.