Testosterone Implants and the Incidence of Breast Cancer

NCT03768258 | Completed

• 1 other identifier: MW0318-TBCP10Y
• Study Type: observational
• Target: 1,268
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of invasive breast cancer

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

  10-year results

Secondary Outcomes (1)

• Incidence of ductal carcinoma in situ

  10-year results

Interventions

Testosterone Implant DRUG

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

Also known as: Testosterone + anastrozole implant

Eligibility Criteria

• Age: 24 Years - 92 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women who presented to the office of Dr. Rebecca Glaser between March 2008- March of 2103 with symptoms of hormone deficiency and received testosterone implant therapy were asked to participate in the study. This current chart review study will examine the 10-year incidence of breast cancer in women accrued to the study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Millennium Wellness LLC: lead

Related Publications (1)

• Glaser RL, York AE, Dimitrakakis C. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019 Dec 30;19(1):1271. doi: 10.1186/s12885-019-6457-8.

  PMID: 31888528 RESULT

Related Links

• Statistical Methods and Results Additional File 1

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Testosterone; Anastrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, PI

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: March 1, 2008
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share