NCT00169299

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
351

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2001

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Vasomotor Symptoms Associated With Menopause

Keywords

MenopauseVasomotorBlack cohoshHerbsHot flashesHTCAM

Outcome Measures

Primary Outcomes (2)

  • Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months.

  • Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months.

Secondary Outcomes (5)

  • Vaginal cytology (vaginal maturation index)at BL, 3 and 12 months.

  • Serum lipids (total cholesterol, HDL and LDL cholesterol, triglycerides) at BL, 3, 6, and 12 months.

  • Bone mineral density (hip and spine dual energy x-ray absorptiometry scan) at BL, 6 and 12 months.

  • Glucose metabolism (insulin, fasting blood glucose) at BL, 3, 6, and 12 months.

  • Coagulation factors (fibrinogen, PAI-1) at BL, 3, 6, and 12 months.

Interventions

Black cohoshDRUG
Multibotanical preparationDRUG
Multibotanical preparation + dietary soy counselingDRUG
Conjugated equine estrogen +/- medroxyprogesterone acetateDRUG

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • age 45 - 55
  • peri- or post-menopausal
  • moderate to severe vasomotor symptoms
  • normal thyroid stimulating hormone
  • proof of normal mammogram within past 2 years

You may not qualify if:

  • use of HT or oral contraceptives within past 3 months
  • use of herbs or alternative or complementary medicines for vasomotor symptoms within past 1 month
  • medical history of contraindications to HT
  • bone mineral density greater than 2 standard deviations below age specific mean
  • bilateral oophorectomy
  • current use of tamoxifen, raloxifene, bisphosphonates, cholesterol-lowering medications, prescription blood-thinners, or oral steroids
  • pregnant or planning to become pregnant
  • allergy to soybeans or soy protein
  • unable to swallow pills
  • current participation in another investigational drug trial
  • intention to move out of area in the next 12 months
  • non-compliance with procedures involved in screening and run-in trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative, Center for Health Studies

Seattle, Washington, 98101-1448, United States

Location

Related Publications (1)

  • Newton KM, Reed SD, LaCroix AZ, Grothaus LC, Ehrlich K, Guiltinan J. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med. 2006 Dec 19;145(12):869-79. doi: 10.7326/0003-4819-145-12-200612190-00003.

    PMID: 17179056DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

black cohosh root extract

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Katherine M Newton, PhD

    Group Health Cooperative, Center for Health Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2001

Study Completion

September 1, 2004

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

US(1)