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TerminatedNCT00068185Updated Dec 11, 2009

A Study of the Pharmacokinetics of Black Cohosh

A Phase 1 interventional study of Black cohosh in Hot Flashes, sponsored by National Center for Complementary and Integrative Health (NCCIH). Terminated at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-11.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 1, Interventional, and Treatment

Why this study was terminated
PI left institution, study did not continue, funding stopped
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

Black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking Remifemin.

Read the detailed description

As per Brief Summary

02

Conditions studied

  • Hot Flashes

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Keywords

  • Black cohosh
  • Pharmacokinetics
  • Alternative therapies
  • Natural product
03

In context

Hot Flashes

293 studies on the registry are indexed under Hot Flashes; 52 are open to participants now.

This study's planned enrollment of 12 is below the median of 90 across 262 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 223 studies on the registry; 7 are open to participants now.

Browse National Center for Complementary and Integrative Health (NCCIH) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix
  • No current prescription medication use
  • Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy
  • Competent to understand and sign informed consent
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

06

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2003, a primary completion of Jul 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2003
First posted
Sep 10, 2003
Start
Aug 2003
Primary completionActual
Jul 2008
CompletionActual
Jul 2008
Last update
Dec 11, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00068185
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
First posted
Sep 10, 2003
Start date
Aug 2003
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Dec 11, 2009

Study contacts

Heather S Shaw, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Black cohosh root extract

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