Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169299
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Brief Title:
Herbal Alternatives for Menopause Symptoms HALT Study
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Herbal Alternatives for Menopause Symptoms A Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Surveys indicate that 25 to 33 of women have moderate to severe menopausal symptoms including hot flashes night sweats and disturbed sleep The treatment of choice in the medical community for these symptoms is hormone replacement therapy which is estrogen and sometimes progestin Many women also use over-the-counter herbal remedies However less is known about how well these products work or their safety Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms
The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms We will also be measuring their effects on other factors known to be affected by hormone replacement therapy cholesterol blood sugar bone density vaginal cell structure and blood clotting
The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms We will also be measuring their effects on other factors known to be affected by hormone replacement therapy cholesterol blood sugar bone density vaginal cell structure and blood clotting
Detailed Description:
Hormone replacement therapy HT estrogen and progestin remains the treatment of choice for women with vasomotor symptoms and long-term HT has been recommended for prevention purposes The demand for alternatives to HT and the availability and use of over-the-counter products including dietary phytoestrogen supplements and naturopathic medicines has grown dramatically Few of these products have faced the rigors of randomized trials and none have been tested to evaluate their effects on long-term outcomes
The purpose of this 4-year randomized controlled trial is to evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat vasomotor symptoms in peri- and postmenopausal women The treatments were chosen because of the scientific evidence supporting a possible benefit the availability of products with adequate quality control their frequency of use in naturopathic medicine and our ability to blind participants to the intervention The 5 proposed treatment arms are 1 conjugated equine estrogen with or without medroxyprogesterone acetate in women with or without an intact uterus respectively 2 a single herbal product black cohosh 3 a multibotanical preparation 4 a combination regimen that includes the same multibotanical preparation plus soy diet counseling and 5 placebo Our primary aim is to compare the effects of three alternative treatments HRT and placebo on the frequency and intensity of vasomotor symptoms measured by The Wiklund Menopause Symptom Checklist and a daily Vasomotor Symptom Diary Our 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 and 5 coagulation factors fibrinogen PAI-1
Our hypotheses are that compared to placebo the three alternative treatments tested in this proposal will reduce frequency of hot flashes and night sweats improve vaginal maturation and decrease vagina atrophy as measured by maturation index lower total cholesterol and LDL with no effect on HDL reduce the rate of decline in bone mineral density BMD and have no effect on glucose metabolism or clotting factors
To accomplish our specific aims we will 1 recruit and randomize approximately peri- and post-women to one of 5 treatment arms for one year 2 collect measurements of primary and secondary outcomes at baseline 3 6 and 12 months and 3 compare changes in outcomes in the groups taking alternative treatments to those in the HRT and placebo groups
The purpose of this 4-year randomized controlled trial is to evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat vasomotor symptoms in peri- and postmenopausal women The treatments were chosen because of the scientific evidence supporting a possible benefit the availability of products with adequate quality control their frequency of use in naturopathic medicine and our ability to blind participants to the intervention The 5 proposed treatment arms are 1 conjugated equine estrogen with or without medroxyprogesterone acetate in women with or without an intact uterus respectively 2 a single herbal product black cohosh 3 a multibotanical preparation 4 a combination regimen that includes the same multibotanical preparation plus soy diet counseling and 5 placebo Our primary aim is to compare the effects of three alternative treatments HRT and placebo on the frequency and intensity of vasomotor symptoms measured by The Wiklund Menopause Symptom Checklist and a daily Vasomotor Symptom Diary Our 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 and 5 coagulation factors fibrinogen PAI-1
Our hypotheses are that compared to placebo the three alternative treatments tested in this proposal will reduce frequency of hot flashes and night sweats improve vaginal maturation and decrease vagina atrophy as measured by maturation index lower total cholesterol and LDL with no effect on HDL reduce the rate of decline in bone mineral density BMD and have no effect on glucose metabolism or clotting factors
To accomplish our specific aims we will 1 recruit and randomize approximately peri- and post-women to one of 5 treatment arms for one year 2 collect measurements of primary and secondary outcomes at baseline 3 6 and 12 months and 3 compare changes in outcomes in the groups taking alternative treatments to 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