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NCT01628536 · ClinicalTrials.gov registry record · NA

A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ

A NA study, sponsored by Yale University.

Completed
Registry status
NA
Development phase
33
Enrollment target

NCT01628536: Completed NA study, sponsored by Yale University.

NCT01628536 is a NA study that has completed, run by Yale University. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01628536, a NA study, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
33 participants
Enrollment target

Study Summary

The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a pre-operative setting.

Primary Outcome

1. Measure change in size of DCIS on routine imaging (i.e. mammography and/or ultrasound) obtained before and after 4 weeks of treatment with black cohosh, with correlation to specimen sizes; and 2. Determine differences in breast epithelial cell proliferation in areas of DCIS as measured by mean change in levels of Ki67 before and after 4 weeks of treatment with black cohosh. Ki67 levels will be assessed with traditional immunohistochemical staining as well as AQUA technology.

Interventions

  • DIETARY_SUPPLEMENT Black cohosh

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2012-06
Est. Completion 2016-06
Phase NA
Yale University

1,492 total trials

What the finished NCT01628536 record still lists

NCT01628536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Black cohosh is the first listed.

NCT01628536 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01628536 about?

NCT01628536 is a clinical study titled "A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ". The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a pre-operative setting.

What is the current status of trial NCT01628536?

This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2012-06. Estimated completion is 2016-06.

What interventions are being tested in trial NCT01628536?

The interventions under investigation include: Black cohosh (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01628536?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01628536's enrollment target sits among peer trials

33 1574th of 2000 higher than 423 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01628536, the US trial registry maintained by the National Library of Medicine. NCT01628536 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.