Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00551785
Other study ID # ZEG2007_01
Secondary ID
Status Terminated
Phase Phase 4
First received October 30, 2007
Last updated March 24, 2015
Start date September 2007
Est. completion date June 2012

Study information

Verified date March 2015
Source Center for Epidemiology and Health Research, Germany
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 328
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Center for Epidemiology and Health Research Berlin

Sponsors (2)

Lead Sponsor Collaborator
Center for Epidemiology and Health Research, Germany Procter and Gamble

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary gynecological cancer; serious cardiovascular diseases Time to event analysis within 8 years Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05337566 - Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections N/A
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Recruiting NCT05537727 - Robotic MIS With Dexter
Completed NCT05037383 - Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions N/A
Completed NCT04080323 - Single-dose Vaginal Dinoprostone and Hysterectomy Phase 3
Not yet recruiting NCT06011538 - Web-based Versus Standard Information for Same Day Hysterectomy (WISH) N/A
Completed NCT03187327 - Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology N/A
Completed NCT00528177 - Morphine vs. Oxycodone for Postoperative Pain Management Phase 4
Completed NCT03641625 - Effect of SmtO2 Guided Care on PONV (iMODIPONV) N/A
Terminated NCT03500744 - Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery N/A
Recruiting NCT03294343 - Risk-Reducing Surgeries for Hereditary Ovarian Cancer N/A
Completed NCT03610425 - A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
Completed NCT05659303 - Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy
Completed NCT05270447 - Short-Term Effects of Connective Tissue Massage After Hysterectomy N/A
Recruiting NCT05031182 - Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique. N/A
Completed NCT03634306 - Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy N/A
Completed NCT01526668 - Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy N/A
Recruiting NCT05374720 - Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy N/A
Recruiting NCT04109989 - Clinical Assessment - HominisTM Surgical System N/A
Recruiting NCT06039566 - NAC vs Placebo on Opioid Use for Hysterectomy Phase 3