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NCT00675688
A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Phase 3 trial testing Bazedoxifene/Conjugate Estrogens (CE) in Endometrial Hyperplasia in 3,544 participants. Completed in 1 January 2006.
1 January 2006
Quick facts
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 3,544 |
| Start date | 1 April 2002 |
| Primary completion | 1 January 2006 |
| Estimated completion | 1 January 2006 |
Drugs / interventions tested
- Bazedoxifene/Conjugate Estrogens (CE) — full drug profile →
- Raloxifene (RALOXIFENE) — full drug profile →
- Placebo
Conditions studied
- Endometrial Hyperplasia — all drugs for Endometrial Hyperplasia →
- Osteoporosis — all drugs for Osteoporosis →
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →
Who can join
Adults 40 to 75, female only, with Endometrial Hyperplasia or Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.
Time frame: one year
Sponsor's own description
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials.
Archer DF, Freeman EW, Komm BS, Ryan KA, et al · · 2016 · cited 5× · PMID 27676118 · DOI 10.1089/jwh.2015.5558 -
Patient considerations in the management of menopausal symptoms: role of conjugated estrogens with bazedoxifene.
Kagan R, Goldstein SR, Pickar JH, Komm BS. · · 2016 · cited 5× · PMID 27103814 · DOI 10.2147/tcrm.s63833
Verify or expand the search:
- PubMed search for NCT00675688
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Endometrial Hyperplasia
Currently open trials in the same condition.
- NCT06904274 — Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months · Phase 3 · recruiting
- NCT07077876 — Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Tre · recruiting
- NCT05903131 — Uterine Preservation Via Lifestyle Transformation · Phase 2 · recruiting
- NCT06501846 — Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding. · NA · recruiting
- NCT06417736 — Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women · NA · recruiting
Other Wyeth is now a wholly owned subsidiary of Pfizer trials
Trials by the same sponsor.
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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 NCT00675688 (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 Wyeth is now a wholly owned subsidiary of Pfizer
- Last refreshed: 9 May 2008
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/NCT00675688.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing