Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women
NCT00484107
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients in whom Premarin vaginal cream is indicated.
- In the opinion of the investigator, sufficient intelligence and motivation for the patient to continue throughout the study.
- Provide signed informed consent.
- Patients not willing to give informed consent.
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Descriptive Information | ||||
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Brief Title | Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women | |||
Official Title | A Postmarketing Surveillance Study Evaluating the Tolerability and Safety of PREMARIN VAGINAL CREAM in Indian Postmenopausal Women | |||
Brief Summary | This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Not Provided | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition | Postmenopause | |||
Intervention | Drug: Conjugated Estrogen Cream (Premarin®) | |||
Study Groups/Cohorts | 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 | Completed | |||
Enrollment | 200 | |||
Original Enrollment | Same as current | |||
Actual Study Completion Date | October 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00484107 | |||
Other Study ID Numbers | 0713V-101833 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 |