Hot FlashesPhase 1NCT00068185
A Study of the Pharmacokinetics of Black Cohosh
A Phase 1 study testing Black cohosh in people with Hot Flashes, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Black cohosh
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Interactions Between SERMs, Soy and Black Cohosh
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
- Conditions
- Hot Flashes
- Being tested
- Black cohosh
- Keywords
- Black cohosh, Pharmacokinetics, Alternative therapies, Natural product
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black cohoshDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2003 (estimated)
- Study startAug 2003
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: PI left institution, study did not continue, funding stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Heather S Shaw, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068185
- Sponsor's protocol ID
- K08AT001315-01A1
- Status last verified
- Dec 2009
- First submitted
- 9 Sep 2003
- Last updated
- 11 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between SERMs, Soy and Black Cohosh
- ClinicalTrials.gov ID
- NCT00068185
- Acronym / sponsor ID
- K08AT001315-01A1
- Conditions
- Hot Flashes
- Keywords
- Black cohosh, Pharmacokinetics, Alternative therapies, Natural product
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution, study did not continue, funding stopped
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As per Brief Summary
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black cohosh | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: PI left institution, study did not continue, funding stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather S Shaw, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Black cohosh in people with Hot Flashes, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left institution, study did not continue, funding stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.