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NCT00706225
An Open-Label, Single/Multiple Dose, Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Bazedoxifene On Conjugated Estrogens (CE) In Healthy Postmenopausal Women
Phase 1 trial testing Bazedoxifene and conjugated estrogens in Postmenopause in 30 participants. Completed in 1 July 2008.
1 July 2008
Quick facts
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 1 June 2008 |
| Primary completion | 1 July 2008 |
| Estimated completion | 1 July 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bazedoxifene and conjugated estrogens — 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 35 to 70, 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 evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women.
Time frame: 3 months
Sponsor's own description
Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis. PREMARIN® (conjugated estrogens \[CE\]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis. The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women. Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.
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 NCT00706225
- 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
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- 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 NCT00706225 (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: 21 September 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/NCT00706225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing