TIBCaP: Testosterone Implants and the Incidence of Breast Cancer

• Sponsor: Millennium Wellness LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT03768258
• Collaborator: (none)
• Enrollment: 1,268
• Actual Duration (Months): 129

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Testosterone Implant

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1268 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW
• Actual Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Outcome Measures

Primary Outcome Measures

1. Incidence of invasive breast cancer [10-year results]

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

Secondary Outcome Measures

1. Incidence of ductal carcinoma in situ [10-year results]

   The incidence of DCIS in women treated with testosterone therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Years to 92 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Millennium Wellness LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Statistical Methods and Results Additional File 1

Publications

None provided.

• Responsible Party: Rebecca L. Glaser, M.D., Physician, PI, Millennium Wellness LLC
• ClinicalTrials.gov Identifier: NCT03768258
• Other Study ID Numbers: MW0318-TBCP10Y
• First Posted: Dec 7, 2018
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Methyltestosterone; Anastrozole; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

No Results Posted as of Sep 5, 2021