Hot FlashesPhase 2NCT00066144
Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms
A Phase 2 study testing Cimicifuga racemosa, Trifolium pratense and Black cohosh in people with Hot Flashes and Menopause, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hot Flashes, Menopause
- What is being tested?
- Cimicifuga racemosa, Trifolium pratense and Black cohosh
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Apr 2006
- Phase
- Phase 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
Who may be able to join
- Menopausal women with intact uterus
- Must be experiencing hot flashes
- No menstrual periods for at least 6 months and no longer than 3 years
- Non-smoker
- Must have intact uterus (no hysterectomy)
Who cannot join
- Contraindications for hormone replacement therapy
- Diabetes mellitus
- Pregnancy or breast-feeding
- Obese (BMI >35 excluded)
- History of endometrial hyperplasia/neoplasia/malignancy
- History of breast or reproductive cancer
Show all 17Show fewer
- History of severe recurrent depression, or severe psychiatric disturbance
- History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
- History of abnormal vaginal bleeding of unknown cause
- Untreated or uncontrolled high blood pressure/hypertension
- Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
- History of hormone-associated migraines
- History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
- Participation in a clinical trial within 30 days
- Abnormal endometrial biopsy or mammogram
- Abnormal transvaginal ultrasound defined as >7mm thickness
- Vegan
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms
This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.
- Conditions
- Hot Flashes, Menopause
- Being tested
- Cimicifuga racemosa, Trifolium pratense, Black cohosh, Red clover
- Keywords
- menopause, hot flashes, red clover, black cohosh, sexual dysfunction
- Medical subject headings
- Hot Flashes, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cimicifuga racemosaDrug
Trifolium pratenseDrug
Black cohoshDrug
Red cloverDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startApr 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Investigators
- Stacie Geller, MD, Principal investigator, Department of Obstetrics and Gynecology University of Illinois, Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066144
- Sponsor's protocol ID
- P50AT000155
- Status last verified
- Oct 2007
- First submitted
- 4 Aug 2003
- Last updated
- 12 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Geller SE, Shulman LP, van Breemen RB, Banuvar S, Zhou Y, Epstein G, Hedayat S, Nikolic D, Krause EC, Piersen CE, Bolton JL, Pauli GF, Farnsworth NR. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009 Nov-Dec;16(6):1156-66. doi: 10.1097/gme.0b013e3181ace49b.
PubMed 19609225
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Cohosh and Red Clover Efficacy for the Relief of Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT00066144
- Acronym / sponsor ID
- P50AT000155
- Conditions
- Hot Flashes, Menopause
- Keywords
- menopause, hot flashes, red clover, black cohosh, sexual dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Study start
- Apr 2003
- Study completion
- Apr 2006 (actual)
- First posted
- 5 Aug 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.
This Phase II study, a follow-up to a Phase I trial in normal volunteers, will determine the efficacy of black cohosh and red clover for the relief of menopausal symptoms. It will also assess the safety of chronic dosing (1 year) by evaluating uterine (endometrial biopsies), breast (mammography), and hematology parameters (CBC and chemistry lab values) at baseline and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Menopausal women with intact uterus
- Must be experiencing hot flashes
- No menstrual periods for at least 6 months and no longer than 3 years
- Non-smoker
- Must have intact uterus (no hysterectomy)
Key exclusion criteria (17 listed)
- Contraindications for hormone replacement therapy
- Diabetes mellitus
- Pregnancy or breast-feeding
- Obese (BMI >35 excluded)
- History of endometrial hyperplasia/neoplasia/malignancy
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 |
|---|---|---|
| Cimicifuga racemosa | Drug | – |
| Trifolium pratense | Drug | – |
| Black cohosh | Drug | – |
| Red clover | 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 12 Oct 2007.
- Derived from this study: PubMed 19609225Geller SE, Shulman LP, van Breemen RB, Banuvar S, Zhou Y, Epstein G, Hedayat S, Nikolic D, Krause EC, Piersen CE, Bolton JL, Pauli GF, Farnsworth NR. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause. 2009 Nov-Dec;16(6):1156-66. doi: 10.1097/gme.0b013e3181ace49b.
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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.
Stacie Geller, MD principal investigator
Department of Obstetrics and Gynecology University of Illinois, Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cimicifuga racemosa, Trifolium pratense and Black cohosh in people with Hot Flashes and Menopause, 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 12 Oct 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 phase mean?
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?
On the ClinicalTrials.gov record for NCT00066144, which also lists 1 linked publication.
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 12 Oct 2007.