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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014