Last reviewed · How we verify
NCT00195455
A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women
Phase 4 trial testing Trimegestone in Postmenopause in 133 participants. Completed in 1 March 2007.
Quick facts
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 133 |
| Start date | 1 February 2005 |
| Estimated completion | 1 March 2007 |
| Sites | 6 locations across Mexico |
Drugs / interventions tested
- Trimegestone (TRIMEGESTONE) — full drug profile →
- 17b Estradiol — full drug profile →
Conditions studied
- Postmenopause — all drugs for Postmenopause →
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →
Who can join
Adults 45 to 55, female only, with Postmenopause. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
Sponsor's own description
The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.
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 NCT00195455
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Postmenopause
Currently open trials in the same condition.
- NCT06813261 — GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women · NA · recruiting
- NCT06951022 — The Effect of Sujok Therapy on Urinary Incontinence and Quality of Life in Postmenopausal Women · NA · active not recruiting
Other Wyeth is now a wholly owned subsidiary of Pfizer trials
Trials by the same sponsor.
- NCT00909688 — Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses · Phase 1 · completed
- NCT00853749 — Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine · Phase 3 · completed
- NCT00894634 — Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents · Phase 1 · completed
- NCT00854009 — Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects · Phase 1 · completed
- NCT00837837 — Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents · Phase 1 · completed
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 NCT00195455 (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: 17 December 2007
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/NCT00195455.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing