This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream...
Date First Received: June 7, 2007
Last Updated: December 20, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 200
Brief Summary
Official Title: “A Postmarketing Surveillance Study Evaluating the Tolerability and Safety of PREMARIN VAGINAL CREAM in Indian Postmenopausal Women”
Condition Keyword(s):
Intervention(s):
This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream.
Study Type: Observational
Study Design: Other
Intervention(s) in this Clinical Trial
- Drug: Conjugated Estrogen Cream (Premarin®)
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients not willing to give informed consent.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00484107
Study ID Number: 0713V-101833
ClinicalTrials.gov Identifier: NCT00484107
Health Authority: India: Ministry of Health
Clinical Trials Authorship and Review
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