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Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women

Last updated on October 13, 2019

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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 TitleTolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women
Official TitleA Postmarketing Surveillance Study Evaluating the Tolerability and Safety of PREMARIN VAGINAL CREAM in Indian Postmenopausal Women
Brief SummaryThis post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignNot Provided
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionPostmenopause
InterventionDrug: Conjugated Estrogen Cream (Premarin®)
Study Groups/CohortsNot 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 StatusCompleted
Enrollment
 (submitted: June 7, 2007)
200
Original EnrollmentSame as current
Actual Study Completion DateOctober 2006
Primary Completion DateNot 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
Ages40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00484107
Other Study ID Numbers0713V-101833
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 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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