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Tracking Information | |
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First Received Date † | June 3, 2003 |
Last Updated Date | December 1, 2005 |
Start Date † | July 2000 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00061711 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Alternative Therapies for Menopause: A Randomized Trial |
Official Title † | |
Brief 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. 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:
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 Phase | |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study |
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 355 |
Completion Date | November 2004 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria
Exclusion Criteria
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Gender | Female |
Ages | 45 Years to 55 Years |
Accepts Healthy Volunteers | Yes |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00061711 |
Responsible Party | |
Secondary IDs †† | 5R01AG017057-03 |
Study Sponsor † | National Institute on Aging (NIA) |
Collaborators †† | |
Investigators † | |
Information Provided By | National Institute on Aging (NIA) |
Verification Date | December 2005 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |