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Testosterone Implants and the Incidence of Breast Cancer (TIBCaP)

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ClinicalTrials.gov Identifier: NCT03768258
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Rebecca L. Glaser, M.D., Millennium Wellness LLC

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
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.

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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 : March 2008
Actual Primary Completion Date : March 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Drug: Testosterone Implant
    Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency
    Other Name: Testosterone + anastrozole implant


Primary Outcome Measures :
  1. Incidence of invasive breast cancer [ Time Frame: 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 [ Time Frame: 10-year results ]
    The incidence of DCIS in women treated with testosterone therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 92 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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

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Responsible Party: Rebecca L. Glaser, M.D., Physician, PI, Millennium Wellness LLC
ClinicalTrials.gov Identifier: NCT03768258     History of Changes
Other Study ID Numbers: MW0318-TBCP10Y
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents