Breast CancerTIBCaPNCT03768258
Testosterone Implants and the Incidence of Breast Cancer
An observational study of Breast Cancer, run by Millennium Wellness LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 92 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Testosterone Implant
- How many people
- 1,268 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 92 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pre-existing breast cancer
- Women who received a single testosterone pellet insertion
About this study
Official title: Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Testosterone Implant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone ImplantDrug
Also called Testosterone + anastrozole implant
Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of invasive breast cancer
The incidence of invasive breast cancer in women treated with testosterone therapy
Measured: 10-year results
Secondary outcomes (1)
Incidence of ductal carcinoma in situ
The incidence of DCIS in women treated with testosterone therapy
Measured: 10-year results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study startMar 2008
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Wellness LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca L. Glaser, M.D., Millennium Wellness LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768258
- Sponsor's protocol ID
- MW0318-TBCP10Y
- Acronym
- TIBCaP
- Status last verified
- Aug 2021
- First submitted
- 4 Dec 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31888528
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW
- ClinicalTrials.gov ID
- NCT03768258
- Acronym / sponsor ID
- TIBCaP / MW0318-TBCP10Y
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,268 participants (actual)
- Lead sponsor
- Millennium Wellness LLCUniversity, hospital or other
- Study start
- Mar 2008 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 92 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pre-existing breast cancer
- Women who received a single testosterone pellet insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone ImplantAlso: Testosterone + anastrozole implantTestosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency | Drug | – |
Primary outcome
Incidence of invasive breast cancer
Time frame: 10-year results
The incidence of invasive breast cancer in women treated with testosterone therapy
1 secondary outcome
Incidence of ductal carcinoma in situ
Time frame: 10-year results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Results publication: PubMed 31888528Glaser 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.
- Statistical Methods and Results Additional File 1Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Millennium Wellness LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of invasive breast cancer (time frame: 10-year results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.