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NCT00167921
A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis.
Phase 1 trial testing Premarin® Vaginal Cream in Atrophic Vaginitis in 24 participants. Completed.
Quick facts
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 24 |
| Start date | 1 October 2005 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Premarin® Vaginal Cream
- Premarin® oral tablets — full drug profile →
Conditions studied
- Atrophic Vaginitis — all drugs for Atrophic Vaginitis →
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →
Who can join
Adults 45 to 80, female only, with Atrophic Vaginitis. 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 characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with oral Premarin® tablets in postmenopausal women with atrophic vaginitis.
Sponsor's own description
The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.
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 NCT00167921
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00167921 (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: 25 May 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/NCT00167921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing