Surveillance Study of Women Taking Intrinsa® (EMPOWER)

This study has been terminated.
(The marketing authorization for Intrinsa was withdrawn.)
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00551785
First received: October 30, 2007
Last updated: November 1, 2012
Last verified: November 2012
  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 4

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

Resource links provided by NLM:


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 ]

Enrollment: 328
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Center for Epidemiology and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Procter and Gamble
Investigators
Principal Investigator: Klaas Heinemann, MD, PhD Center for Epidemiology and Health Research, Germany
  More Information

No publications provided

Responsible Party: Klaas Heinemann, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00551785     History of Changes
Other Study ID Numbers: ZEG2007_01
Study First Received: October 30, 2007
Last Updated: November 1, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Center for Epidemiology and Health Research, Germany:
Hypoactive Sexual Desire Disorder
Menopause
Androgen

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone
Testosterone enanthate
Testosterone undecanoate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens

ClinicalTrials.gov processed this record on July 31, 2014