Surveillance Study of Women Taking Intrinsa® (EMPOWER)
|First Received Date ICMJE||October 30, 2007|
|Last Updated Date||November 1, 2012|
|Start Date ICMJE||September 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||gynecological cancer; serious cardiovascular diseases [ Time Frame: Time to event analysis within 8 years ] [ Designated as safety issue: Yes ]|
|Original Primary Outcome Measures ICMJE
||breast cancer; serious cardiovascular diseases [ Time Frame: during the study ]|
|Change History||Complete list of historical versions of study NCT00551785 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Surveillance Study of Women Taking Intrinsa®|
|Official Title ICMJE||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.
This is a prospective, controlled, non-interventional long-term cohort study of women who are prescribed estrogen therapy or estrogen therapy in combination with Intrinsa®.
Intrinsa® is a transdermal patch that delivers 300 mcg of testosterone daily through the skin of the abdomen, providing women with testosterone levels that are within the physiological range for premenopausal women. It is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in women with bilateral oophorectomy and hysterectomy who are receiving concomitant estrogen therapy.
A non-interference approach will be used to provide standardized, comprehensive, reliable information on these treatments under routine medical conditions.
The two main objectives of this study are:
The primary variable for the statistical analysis is the breast cancer hazard ratio for Intrinsa® users in comparison to users of estrogen therapy.
The secondary objectives of the study are:
The two study cohorts will consist of new users of Intrinsa® in combination with estrogen therapy and estrogen therapy without simultaneous use of Intrinsa®, respectively. After study entry cohort members will be followed for a period of five to eight years for rare serious safety outcomes. Regular, active contacts with the cohort members by the ZEG study team (=active surveillance) will provide the necessary information on health-related events or changes in health status. All cohort members will be contacted at 6 and 12 months after study entry, and then every 12 months.
Approximately 5.400 subjects per cohort will be recruited by participating physicians in order to provide 50.000 women-years (WY) of observation, assuming a withdrawal rate of 10% per year. Enrollment procedures should not interfere with the prescribing behavior of physicians or with the individual needs of the participating women.
The study will be conducted in Italy, France, Spain, the UK and Germany. It could be extended to other countries based on the international registration and launch status of Intrinsa®.
The study will be divided into two phases: a clinic phase, which includes an initial consultation at baseline with a participating physician, and a follow-up phase, which includes two follow-up contacts within the first year, and then annual follow-up contacts for up to eight years post-baseline.
The study participants are women who have a new prescription of Intrinsa® in combination with estrogen therapy or estrogen therapy respectively and who are willing to participate in this cohort study. There are no specific medical inclusion or exclusion criteria other than the guidance provided by the local product label. However, women who are not cooperative may be excluded from study participation. Also women with a language barrier will not be eligible for study inclusion.
This study will maintain scientific independence and will be governed by an independent Advisory Council. The Center for Epidemiology and Health Research in Berlin, Germany and its research team will be accountable for the Advisory Council (AC) in all scientific matters. The members of the AC wil be international experts in relevant scientific fields (e. g. epidemiology, gynecology and cardiology).
Information on the identity of the patients and treating physicians will be kept separated from the clinical information throughout the study. All relevant national data protection laws will be followed.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Women prescribed estrogen therapy or estrogen therapy in combination with Intrinsa
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Estimated Completion Date||December 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Germany|
|NCT Number ICMJE||NCT00551785|
|Other Study ID Numbers ICMJE||ZEG2007_01|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany|
|Study Sponsor ICMJE||Center for Epidemiology and Health Research, Germany|
|Collaborators ICMJE||Procter and Gamble|
|Information Provided By||Center for Epidemiology and Health Research, Germany|
|Verification Date||November 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP