Surveillance Study of Women Taking Intrinsa® - Full Text View

Surveillance Study of Women Taking Intrinsa® (EMPOWER)

This study is currently recruiting participants.

Verified by Center for Epidemiology and Health Research, Germany, December 2008

Sponsors and Collaborators:	Center for Epidemiology and Health Research, Germany Procter and Gamble
Information provided by:	Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:	NCT00551785

Purpose

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.

Condition	Phase
Ovariectomy Hysterectomy Hypoactive Sexual Desire Disorder	Phase IV

MedlinePlus related topics: Hysterectomy

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Multinational Postmarketing Observational Study of Women Prescribed Intrinsa

Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:

gynecological cancer; serious cardiovascular diseases [ Time Frame: Time to event analysis within 8 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10800
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2014

Groups/Cohorts
1 Women prescribed Intrinsa and estrogen therapy
2 Women prescribed estrogen therapy

Show Detailed Description

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women prescribed estrogen therapy or estrogen therapy in combination with Intrinsa

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551785

Contacts

Contact: Mathias Altmann, MPH, PhD	+493094510127	altmann@zeg-berlin.de
Contact: Anita Assmann, MSc	+493094510130	assmann@zeg-berlin.de

Locations

Germany
Center for Epidemiology and Health Research	Recruiting
Berlin, Germany, 10115
Contact: Mathias Altmann, MPH, PhD +493094510127 altmann@zeg-berlin.de
Contact: Anita Assmann, MSc +493094510130 assmann@zeg-berlin.de
Principal Investigator: Juergen C Dinger, MD, PhD

Sponsors and Collaborators

Center for Epidemiology and Health Research, Germany

Procter and Gamble

Investigators

Principal Investigator:

Juergen C Dinger, MD, PhD

Center for Epidemiology and Health Research, Germany

More Information

Responsible Party:	Center for Epidemiology and Health Research, Germany ( Juergen C Dinger, MD, PhD, Principal Investigator )
Study ID Numbers:	ZEG2007_01
Study First Received:	October 30, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00551785
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Center for Epidemiology and Health Research, Germany:

Hypoactive Sexual Desire Disorder
Menopause
Androgen

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Signs and Symptoms
Testosterone
Mental Disorders
Neurologic Manifestations

Methyltestosterone
Hypokinesia
Dyskinesias
Menopause
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Nervous System Diseases
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 15, 2009