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NCT00484107 Clinical Trial

Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women

Postmenopause Clinical Trial

Official title:
A Postmarketing Surveillance Study Evaluating the Tolerability and Safety of PREMARIN VAGINAL CREAM in Indian Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00484107
Other study ID # 0713V-101833
Secondary ID
Status Completed
Phase Phase 4
First received June 7, 2007
Last updated December 20, 2007
Start date September 2005
Est. completion date October 2006

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Observational

Clinical Trial Summary

This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Conjugated Estrogen Cream (Premarin®)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer
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