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Surveillance Study of Women Taking Intrinsa® (EMPOWER)

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ClinicalTrials.gov Identifier: NCT00551785
Recruitment Status : Terminated (The marketing authorization for Intrinsa was withdrawn.)
First Posted : October 31, 2007
Last Update Posted : March 25, 2015
Procter and Gamble
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany

Brief Summary:
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 or disease Phase
Ovariectomy Hysterectomy Hypoactive Sexual Desire Disorder Phase 4

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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.

Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Multinational Postmarketing Observational Study of Women Prescribed Intrinsa
Study Start Date : September 2007
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Women prescribed Intrinsa and estrogen therapy
Women prescribed estrogen therapy

Primary Outcome Measures :
  1. gynecological cancer; serious cardiovascular diseases [ Time Frame: Time to event analysis within 8 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551785

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

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
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany:
Hypoactive Sexual Desire Disorder

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