Testosterone Implants and the Incidence of Breast Cancer

Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03768258

Acronym

TIBCaP

Enrollment

1268

Registered

2018-12-07

Start date

2008-03-31

Completion date

2018-12-31

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGTestosterone Implant

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

24 Years to 92 Years

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

Exclusion criteria

* Pre-existing breast cancer * Women who received a single testosterone pellet insertion

Design outcomes

Primary

Measure	Time frame	Description
Incidence of invasive breast cancer	10-year results	The incidence of invasive breast cancer in women treated with testosterone therapy

Secondary

Measure	Time frame	Description
Incidence of ductal carcinoma in situ	10-year results	The incidence of DCIS in women treated with testosterone therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026