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NCT00472004
A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.
Phase 4 trial testing 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) in Vasomotor Symptoms in 204 participants. Completed in 1 December 2009.
1 December 2009
Quick facts
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 204 |
| Start date | 1 February 2006 |
| Primary completion | 1 December 2009 |
| Estimated completion | 1 December 2009 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) — full drug profile →
- Tibolone (Livial) — full drug profile →
Conditions studied
- Vasomotor Symptoms — all drugs for Vasomotor Symptoms →
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →
Who can join
Adults 45 to 55, female only, with Vasomotor Symptoms. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Decreased of Vasomotor Symptoms [from baseline to six and twelve months]
Time frame: 1 year
Sponsor's own description
This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00472004
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vasomotor Symptoms
Currently open trials in the same condition.
- NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
- NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
- NCT07112651 — Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause · NA · recruiting
- NCT07042516 — Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS). · Phase 2 · recruiting
- NCT06628388 — Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong · NA · recruiting
Other Wyeth is now a wholly owned subsidiary of Pfizer trials
Trials by the same sponsor.
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- NCT00854009 — Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects · Phase 1 · completed
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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 NCT00472004 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wyeth is now a wholly owned subsidiary of Pfizer
- Last refreshed: 28 October 2010
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/NCT00472004.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing