MenopausePhase 1/2NCT00064831
Black Cohosh Extract in Postmenopausal Breast Health
A Phase 1/2 study testing Black Cohosh Extract (BCE) in people with Menopause and Hot Flashes, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Black Cohosh Extract (BCE)
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Feb 2007
- Phase
- Phase 1/2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
- Postmenopausal females
- 20 months since any breastfeeding
- Active postmenopausal symptoms, i.e., hot flashes
- At least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed
- Able to make 4 visits during the trial to the study clinic in Columbia, Missouri
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65212
About this study
Official title: The Effect of Black Cohosh Extract on the Human Breast
The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.
Read the detailed description
As in Brief Summary
- Conditions
- Menopause, Hot Flashes
- Being tested
- Black Cohosh Extract (BCE)
- Keywords
- estrogen stimulation, relief of hot flashes, nipple aspirate fluid, body fluid levels of black cohosh
- 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 Cohosh Extract (BCE)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study startJul 2003
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Missouri-Columbia
- Investigators
- Edward Sauter, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064831
- Sponsor's protocol ID
- R21AT001102-01
- Other IDs
- SauterE
- Status last verified
- Dec 2007
- First submitted
- 14 Jul 2003
- Last updated
- 7 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Black Cohosh Extract on the Human Breast
- ClinicalTrials.gov ID
- NCT00064831
- Acronym / sponsor ID
- R21AT001102-01
- Conditions
- Menopause, Hot Flashes
- Keywords
- estrogen stimulation, relief of hot flashes, nipple aspirate fluid, body fluid levels of black cohosh
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- University of Missouri-Columbia
- Study start
- Jul 2003
- Study completion
- Feb 2007 (actual)
- First posted
- 15 Jul 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.
The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.
Detailed description
As in Brief Summary
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 Extract (BCE) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2007.
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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.
Edward Sauter, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Black Cohosh Extract (BCE) in people with Menopause and 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2007. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 7 Dec 2007.