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Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women

Last updated on February 23, 2020

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients not willing to give informed consent.

NCT00484107
Pfizer
Completed
Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women

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Descriptive Information
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
 (submitted: June 7, 2007)
200
Original Enrollment Same as current
Actual Study Completion Date October 2006
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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