Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women
NCT00484107
Last updated date
ABOUT THIS STUDY
This post-marketing study will provide local safety and tolerance data on the use of
Premarin® vaginal cream.
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
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
Adult Trials: 18+ Years
40-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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.
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Advanced Information
| 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 | 200 | |||
| Original Enrollment | Same as current | |||
| Actual Study Completion Date | October 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | December 2007 | |||