Alternative Therapies for Menopause: A Randomized Trial

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Hormones; Phytoestrogens

Criteria

Inclusion Criteria

1. Female, aged 45-55.

2. 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.

3. 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.

4. Normal thyroid stimulating hormone (TSH) measured prior to study entry, defined as 0.4

• 5.0 ulU/ML.

5. 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.

6. Must provide informed consent.

7. 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.

Exclusion Criteria

1. Mentally or legally incapacitated such that informed consent cannot be obtained.

2. Use of hormone replacement therapy or oral contraceptives within the past three months.

3. Use of alternative or complementary medicines or herbs for menopausal symptoms within the past one month.

4. 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.

5. 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.

6. Bone mineral density of the hip or spine more than two standard deviations below the age-specific mean.

7. bilateral oophorectomy.

8. Current use of any of the following medications: tamoxifen, raloxifene, bisphosphonates, cholesterol-lowering medications, prescription blood-thinners, or oral steroids.

9. Pregnant or planning to become pregnant.

10. Baseline blood pressure greater than 160/95 mm Hg.

11. Alergy to soybeans or soy protein.

12. Unable to swallow pills.

13. Current participation in another investigational drug trial.

14. Intention to move within the next 12 months rendering follow-up per the protocol impossible.

15. 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).