Testosterone Implants and the Incidence of Breast Cancer (TIBCaP)

Millennium Wellness

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Testosterone Implant

Study type: Observational

Funder types: Other

Identifiers

NCT03768258

MW0318-TBCP10Y

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,268 patients

Sex: Female

Ages: 24 to 92 years old

Volunteers: No Healthy Volunteers

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