Testosterone Implants and the Incidence of Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1268 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2018-12-31

Brief Summary

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This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.

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Detailed Description

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A prior ten-year prospective, observational, study was initially approved in March of 2008 by the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio 45005 and registered through the Office for Human Research Protections (OHRP). Expedited approval continued annually through 2013 at which time the IRB board was closed. All participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Testosterone Implant

Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency

Intervention Type DRUG

Other Intervention Names

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Testosterone + anastrozole implant

Eligibility Criteria

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Inclusion Criteria

* Female patients treated between March 2008 - March 2013
* Women who received at least two testosterone pellet insertion procedures
* Women previously accrued to the prospective cohort study