Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00484107
First received: June 7, 2007
Last updated: December 20, 2007
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Postmenopause
Drug: Conjugated Estrogen Cream (Premarin®)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 200
Study Start Date: September 2005
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484107

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00484107     History of Changes
Other Study ID Numbers: 0713V-101833
Study First Received: June 7, 2007
Last Updated: December 20, 2007
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014