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(The marketing authorization for Intrinsa was withdrawn.)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

  Hide Detailed Description

Detailed Description:

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:

  • to estimate the incidence of breast cancer, other gynecological cancer, myocardial infarction, other cardiovascular outcomes and other rare serious adverse outcomes among Intrinsa® users in actual clinical practice, and
  • to compare these incidences with the incidences found in the comparison group of women with bilateral oophorectomy and hysterectomy using estrogen therapy.

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:

  • to analyze the Intrinsa® utilization pattern in a study population that is representative for the users of this novel treatment
  • to characterize the baseline risk of Intrinsa® users for breast cancer and cardiovascular diseases and
  • to investigate the reversibility of specific androgenic outcomes after stop of treatment.

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.

  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 22, 2014