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Completed

NCT Number: NCT03768258

Testosterone Implants and the Incidence of Breast Cancer

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

24 year–92 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone Implant

Drug

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

Other names: Testosterone + anastrozole implant

Primary outcomes

  1. Incidence of invasive breast cancer

    Time frame: 10-year results

    The incidence of invasive breast cancer in women treated with testosterone therapy

Secondary outcomes

  1. Incidence of ductal carcinoma in situ

    Time frame: 10-year results

    The incidence of DCIS in women treated with testosterone therapy

Sponsors and collaborators

Lead sponsor

Millennium Wellness LLC

Other

Registry information

Official study title

Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW

Acronym: TIBCaP

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2018
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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