Last reviewed · How we verify
NCT00169299
Herbal Alternatives for Menopause Symptoms: A Randomized Trial
Phase 4 trial testing Black cohosh in Vasomotor Symptoms Associated With Menopause in 351 participants. Status unknown.
Quick facts
| Lead sponsor | Kaiser Permanente |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 351 |
| Start date | 1 June 2001 |
| Estimated completion | 1 September 2004 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Black cohosh — full drug profile →
- Multibotanical preparation — full drug profile →
- Multibotanical preparation + dietary soy counseling — full drug profile →
- Conjugated equine estrogen +/- medroxyprogesterone acetate — full drug profile →
Conditions studied
- Vasomotor Symptoms Associated With Menopause — all drugs for Vasomotor Symptoms Associated With Menopause →
Sponsor
Kaiser Permanente — full company profile →
Who can join
Adults 45 to 55, female only, with Vasomotor Symptoms Associated With Menopause. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- 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.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial.
Newton KM, Reed SD, LaCroix AZ, Grothaus LC, et al · · 2006 · cited 176× · PMID 17179056 · DOI 10.7326/0003-4819-145-12-200612190-00003
Verify or expand the search:
- PubMed search for NCT00169299
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00169299 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kaiser Permanente
- Last refreshed: 12 September 2005
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00169299.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing