Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061711
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2003-06-03
Brief Title:
Alternative Therapies for Menopause A Randomized Trial
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US women are in the peri- and post-menopausal age range 45 - 55 and by the year 2015 nearly half of US 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 Womens 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
1 vaginal cytology vaginal maturation index
2 serum lipids total cholesterol HDL and LDL cholesterol triglycerides
3 bone mineral density hip and spine dual energy x-ray absorptiometry scan
4 glucose metabolism insulin fasting blood glucose
5 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
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 Womens 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
1 vaginal cytology vaginal maturation index
2 serum lipids total cholesterol HDL and LDL cholesterol triglycerides
3 bone mineral density hip and spine dual energy x-ray absorptiometry scan
4 glucose metabolism insulin fasting blood glucose
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG017057-03 | NIH | None | httpsreporternihgovquickSearch5R01AG017057-03 |