Hysterectomy Clinical Trial
— EMPOWEROfficial title:
The Multinational Postmarketing Observational Study of Women Prescribed Intrinsa
The primary objective of the study is to assess the risks of testosterone transdermal patch use in a representative study population. The primary clinical outcome of interest is breast cancer.
Status | Terminated |
Enrollment | 328 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All women with bilateral oophorectomy and hysterectomy who receive a new prescription for the study medication or who were prescribed it for a period of six months or less before study entry Exclusion Criteria: - Women who at baseline have used Intrinsa® or the new estrogen therapy for more than six months - Women who do not consent to participate in the study |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Center for Epidemiology and Health Research | Berlin |
Lead Sponsor | Collaborator |
---|---|
Center for Epidemiology and Health Research, Germany | Procter and Gamble |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | gynecological cancer; serious cardiovascular diseases | Time to event analysis within 8 years | Yes |
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