Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
NCT00167921
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrophic Vaginitis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
45-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Generally healthy postmenopausal women.
- Intact uterus.
- Clinical diagnosis of moderate to severe atrophic vaginitis.
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Atrophic VaginitisStudy Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
NCT00167921
- Miami, Florida
- Baltimore, Maryland
Female
45 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis | |||
| Official Title ICMJE | A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis. | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
| Condition ICMJE | Atrophic Vaginitis | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 24 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 45 Years to 80 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00167921 | |||
| Other Study ID Numbers ICMJE | 0713S5-414 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | May 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||