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NCT00238732
A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women
Phase 3 trial testing Bazedoxifene/Conjugated Estrogen in Vaginal Atrophy in 650 participants. Completed in 1 March 2007.
Quick facts
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 650 |
| Start date | 1 October 2005 |
| Estimated completion | 1 March 2007 |
| Sites | 63 locations across United States |
Drugs / interventions tested
- Bazedoxifene/Conjugated Estrogen — full drug profile →
Conditions studied
- Vaginal Atrophy — all drugs for Vaginal Atrophy →
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →
Who can join
Adults 40 to 65, female only, with Vaginal Atrophy. 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.
- Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
- Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Sponsor's own description
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning.
Pinkerton JV, Bushmakin AG, Komm BS, Abraham L. · · 2017 · cited 28× · PMID 28539177 · DOI 10.1016/j.maturitas.2017.03.315
Verify or expand the search:
- PubMed search for NCT00238732
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bazedoxifene/Conjugated Estrogen
Trials testing the same drug.
- NCT03740009 — Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause" · Phase 4 · completed
Other recruiting trials for Vaginal Atrophy
Currently open trials in the same condition.
- NCT05457972 — Postpartum Vaginal Estrogen for Breastfeeding Patients · Phase 4 · recruiting
- NCT06028009 — PRP Injections for Genitourinary Syndrome of Menopause · NA · active not recruiting
- NCT07024667 — Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vagin · NA · recruiting
- NCT05335317 — Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser · NA · recruiting
- NCT04807894 — Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo · Phase 4 · 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 NCT00238732 (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: 19 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/NCT00238732.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing