MenopauseNCT00061711
Alternative Therapies for Menopause: A Randomized Trial
A study testing Hormone Replacement Therapy, Cimicifuga racemosa (Black Cohosh) and Multibotanical phytoestrogen formula in people with Menopause and Hot Flashes, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
This randomized, controlled trial will evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat hot flashes and night sweats in peri- and post-menopausal women. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Hormone Replacement Therapy, Cimicifuga racemosa (Black Cohosh) and Multibotanical phytoestrogen formula
- How many people
- 355 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to Dec 2005
- Phase
- Interventional
- 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 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged 45-55.
- Peri- or post-menopausal, defined as having no menstrual periods for at least 12 months prior to study entry, or skipping at least one menstrual period in the 12 months prior to study entry. Peri- or post-menopausal status will be determined for candidates who have had the uterus removed by an assessment of blood follicle stimulating hormone (FSH). Women with an FSH level higher than 20 mlU/mL will be eligible for the study.
- Experiencing an average of 2 or more hot flashes or night sweats per day, of which 6 or more must be of moderate or greater intensity over two weeks.
- Normal thyroid stimulating hormone (TSH) measured prior to study entry, defined as 0.4 - 5.0 ulU/ML.
- Proof of negative mammogram within two years prior to randomization. Subjects may provide copies of the mammogram results or a letter from their primary care provider.
- Must provide informed consent.
- Not at high risk for medical complications that might affect the subject's ability to complete the trial without a serious co-morbid event, based on medical history, physical examination and laboratory screening evaluation.
Who cannot join
- Mentally or legally incapacitated such that informed consent cannot be obtained.
- Use of hormone replacement therapy or oral contraceptives within the past three months.
- Use of alternative or complementary medicines or herbs for menopausal symptoms within the past one month.
- History of any illness or having significant abnormalities on prestudy clinical or laboratory evaluation such that in the opinion of the investigator participating in this study might pose an unacceptable risk to the subject.
- The subject has a medical history of any of the following contraindications to HRT: breast cancer, uterine cancer, endometrial hyperplasia, angina treated with medication, myocardial infarction, revascularization surgery, coronary angioplasty, stroke, blood clots, active chronic liver disease, or nephrotic syndrome.
- Bone mineral density of the hip or spine more than two standard deviations below the age-specific mean.
Show all 15Show fewer
- bilateral oophorectomy.
- Current use of any of the following medications: tamoxifen, raloxifene, bisphosphonates, cholesterol-lowering medications, prescription blood-thinners, or oral steroids.
- Pregnant or planning to become pregnant.
- Baseline blood pressure greater than 160/95 mm Hg.
- Alergy to soybeans or soy protein.
- Unable to swallow pills.
- Current participation in another investigational drug trial.
- Intention to move within the next 12 months rendering follow-up per the protocol impossible.
- Noncompliance in the procedures involved with the screening visit or run-in trial. To be compliant, subjects must take at least 80% of the run-in medication (can miss 2-1/2 days) and complete at least 80% of the baseline symptom diaries (can miss 3 days of the hot flash and night sweats diaries, must complete all Wiklund checklists).
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Studies Research Clinic
Seattle, Washington, 98101
About this study
This randomized, controlled trial will evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat hot flashes and night sweats in peri- and post-menopausal women. The treatments were chosen because of the scientific evidence supporting a possible benefit, the availability of products with adequate quality control, and their frequency of use in naturopathic medicine. RECRUITMENT FOR THIS STUDY SHOULD END BY AUGUST 1, 2003.
Read the detailed description
Over 17 million U.S. women are in the peri- and post-menopausal age range (45 - 55), and by the year 2015 nearly half of U.S. women will be post-menopausal. Of these, 25-33% will experience moderate to severe menopausal symptoms, and all will be faced with decisions related to maintaining their health through mid-life and beyond. Hormone Replacement Therapy (HRT) is the standard pharmacologic intervention for menopausal symptoms against which other therapies are measured. Concerns about breast cancer and thromboembolism risk, the need for safe alternatives for symptom relief among women in whom HRT is contraindicated, and the resistance to HRT due to its side effects fuel the search for alternatives.
The primary aim of this randomized, controlled trial is to compare the effects of three alternative treatments utilizing phytoestrogens, HRT, and placebo on the frequency and intensity of vasomotor symptoms measured by the Wiklund Menopause Symptom Checklist and daily vasomotor symptom diaries. The alternative treatments chosen for the study are a single herbal formula of black cohosh, a multibotanical formula containing black cohosh, alfalfa, boron, chasteberry, dong quai, false unicorn, licorice, oats, pomegranate, and Siberian ginseng, and soy diet counseling in addition to the multibotanical formula.
The findings of the Women's Health Initiative study published in July 2002 gave the medical and research communities new information about the long-term risk of HRT use. In response to these findings, the study design allows women to be randomized either to the 5-arm trial that includes HRT, or to be randomized only to 4 of the 5 arms: one of the three herbal groups or placebo, without the chance of being assigned to HRT.
Secondary aims are to compare the effects of three alternative treatments, HRT, and placebo on:
- vaginal cytology (vaginal maturation index)
- serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
- bone mineral density (hip and spine dual energy x-ray absorptiometry scan)
- glucose metabolism (insulin, fasting blood glucose)
- clotting factors (fibrinogen, PAI-1).
Approximately 400 peri- and post-menopausal women will be recruited and randomized to one of 5 or one of 4 treatment arms for one year. Primary and secondary outcomes will be measured at baseline, 3, 6, and 12 months. Changes in outcomes will be compared between the groups taking alternative treatments and those in the HRT and placebo groups.
- Conditions
- Menopause, Hot Flashes
- Being tested
- Hormone Replacement Therapy, Cimicifuga racemosa (Black Cohosh), Multibotanical phytoestrogen formula
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone Replacement TherapyDrug
Cimicifuga racemosa (Black Cohosh)Drug
Multibotanical phytoestrogen formulaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2003 (estimated)
- Study startJul 2000
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 355 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061711
- Sponsor's protocol ID
- AG0003
- Other IDs
- 5R01AG017057-03
- Status last verified
- Dec 2009
- First submitted
- 3 Jun 2003
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Newton KM, Buist DS, Keenan NL, Anderson LA, LaCroix AZ. Use of alternative therapies for menopause symptoms: results of a population-based survey. Obstet Gynecol. 2002 Jul;100(1):18-25. doi: 10.1016/s0029-7844(02)02005-7.
PubMed 12100799Phelan EA, Buist DS, Anderson LA, Newton KM, Delaney KM, LaCroix AZ. Understanding attitudes of older women toward hormone replacement therapy. Prev Med. 2001 Jan;32(1):49-56. doi: 10.1006/pmed.2000.0768.
PubMed 11162326Newton KM, LaCroix AZ, Leveille SG, Rutter C, Keenan NL, Anderson LA. Women's beliefs and decisions about hormone replacement therapy. J Womens Health. 1997 Aug;6(4):459-65. doi: 10.1089/jwh.1997.6.459.
PubMed 9279834Newton KM, LaCroix AZ, Buist DS, Keenan NL. The use of alternative and complementary medicine by women enrolled in an HMO setting. Menopause, 1998, 5:244.
Newton KM, Reed SD, Grothaus L, Ehrlich K, Guiltinan J, Ludman E, Lacroix AZ. The Herbal Alternatives for Menopause (HALT) Study: background and study design. Maturitas. 2005 Oct 16;52(2):134-46. doi: 10.1016/j.maturitas.2005.01.007.
PubMed 16186076
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
- Alternative Therapies for Menopause: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00061711
- Acronym / sponsor ID
- AG0003
- Conditions
- Menopause, Hot Flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Jul 2000
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 4 Jun 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 randomized, controlled trial will evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat hot flashes and night sweats in peri- and post-menopausal women. The treatments were chosen because of the scientific evidence supporting a possible benefit, the availability of products with adequate quality control, and their frequency of use in naturopathic medicine. RECRUITMENT FOR THIS STUDY SHOULD END BY AUGUST 1, 2003.
Detailed description
Over 17 million U.S. women are in the peri- and post-menopausal age range (45 - 55), and by the year 2015 nearly half of U.S. women will be post-menopausal. Of these, 25-33% will experience moderate to severe menopausal symptoms, and all will be faced with decisions related to maintaining their health through mid-life and beyond. Hormone Replacement Therapy (HRT) is the standard pharmacologic intervention for menopausal symptoms against which other therapies are measured. Concerns about breast cancer and thromboembolism risk, the need for safe alternatives for symptom relief among women in whom HRT is contraindicated, and the resistance to HRT due to its side effects fuel the search for alternatives.
The primary aim of this randomized, controlled trial is to compare the effects of three alternative treatments utilizing phytoestrogens, HRT, and placebo on the frequency and intensity of vasomotor symptoms measured by the Wiklund Menopause Symptom Checklist and daily vasomotor symptom diaries. The alternative treatments chosen for the study are a single herbal formula of black cohosh, a multibotanical formula containing black cohosh, alfalfa, boron, chasteberry, dong quai, false unicorn, licorice, oats, pomegranate, and Siberian ginseng, and soy diet counseling in addition to the multibotanical formula.
The findings of the Women's Health Initiative study published in July 2002 gave the medical and research communities new information about the long-term risk of HRT use. In response to these findings, the study design allows women to be randomized either to the 5-arm trial that includes HRT, or to be randomized only to 4 of the 5 arms: one of the three herbal groups or placebo, without the chance of being assigned to HRT.
Secondary aims are to compare the effects of three alternative treatments, HRT, and placebo on:
- vaginal cytology (vaginal maturation index)
- serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
- bone mineral density (hip and spine dual energy x-ray absorptiometry scan)
- glucose metabolism (insulin, fasting blood glucose)
- clotting factors (fibrinogen, PAI-1).
Approximately 400 peri- and post-menopausal women will be recruited and randomized to one of 5 or one of 4 treatment arms for one year. Primary and secondary outcomes will be measured at baseline, 3, 6, and 12 months. Changes in outcomes will be compared between the groups taking alternative treatments and those in the HRT and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female, aged 45-55.
- Peri- or post-menopausal, defined as having no menstrual periods for at least 12 months prior to study entry, or skipping at least one menstrual period in the 12 months prior to study entry. Peri- or post-menopausal status will be determined for candidates who have had the uterus removed by an assessment of blood follicle stimulating hormone (FSH). Women with an FSH level higher than 20 mlU/mL will be eligible for the study.
- Experiencing an average of 2 or more hot flashes or night sweats per day, of which 6 or more must be of moderate or greater intensity over two weeks.
- Normal thyroid stimulating hormone (TSH) measured prior to study entry, defined as 0.4 - 5.0 ulU/ML.
- Proof of negative mammogram within two years prior to randomization. Subjects may provide copies of the mammogram results or a letter from their primary care provider.
Key exclusion criteria (15 listed)
- Mentally or legally incapacitated such that informed consent cannot be obtained.
- Use of hormone replacement therapy or oral contraceptives within the past three months.
- Use of alternative or complementary medicines or herbs for menopausal symptoms within the past one month.
- History of any illness or having significant abnormalities on prestudy clinical or laboratory evaluation such that in the opinion of the investigator participating in this study might pose an unacceptable risk to the subject.
- The subject has a medical history of any of the following contraindications to HRT: breast cancer, uterine cancer, endometrial hyperplasia, angina treated with medication, myocardial infarction, revascularization surgery, coronary angioplasty, stroke, blood clots, active chronic liver disease, or nephrotic syndrome.
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 |
|---|---|---|
| Hormone Replacement Therapy | Drug | – |
| Cimicifuga racemosa (Black Cohosh) | Drug | – |
| Multibotanical phytoestrogen formula | 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 11 Dec 2009.
- Background: PubMed 12100799Newton KM, Buist DS, Keenan NL, Anderson LA, LaCroix AZ. Use of alternative therapies for menopause symptoms: results of a population-based survey. Obstet Gynecol. 2002 Jul;100(1):18-25. doi: 10.1016/s0029-7844(02)02005-7.
- Background: PubMed 11162326Phelan EA, Buist DS, Anderson LA, Newton KM, Delaney KM, LaCroix AZ. Understanding attitudes of older women toward hormone replacement therapy. Prev Med. 2001 Jan;32(1):49-56. doi: 10.1006/pmed.2000.0768.
- Background: PubMed 9279834Newton KM, LaCroix AZ, Leveille SG, Rutter C, Keenan NL, Anderson LA. Women's beliefs and decisions about hormone replacement therapy. J Womens Health. 1997 Aug;6(4):459-65. doi: 10.1089/jwh.1997.6.459.
- BackgroundNewton KM, LaCroix AZ, Buist DS, Keenan NL. The use of alternative and complementary medicine by women enrolled in an HMO setting. Menopause, 1998, 5:244.
- Results publication: PubMed 16186076Newton KM, Reed SD, Grothaus L, Ehrlich K, Guiltinan J, Ludman E, Lacroix AZ. The Herbal Alternatives for Menopause (HALT) Study: background and study design. Maturitas. 2005 Oct 16;52(2):134-46. doi: 10.1016/j.maturitas.2005.01.007.
Related trials for Menopause
Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hormone Replacement Therapy, Cimicifuga racemosa (Black Cohosh) and Multibotanical phytoestrogen formula in people with Menopause and Hot Flashes, run by National Institute on Aging (NIA) 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 7 inclusion and 15 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 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.
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 NCT00061711, which also lists 5 linked publications.
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.