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Hormone Therapy

Testosterone Cypionate for Pain

Brigham and Women's Hospital, Boston, MA
Targeting 3 different conditionsTestosterone Cypionate +1 morePhase 2RecruitingResearch Sponsored by Brigham and Women's Hospital

Study Summary

This trial is testing whether testosterone replacement can help improve pain, sexual function, and quality of life for women with chronic back pain who also have low testosterone.

Eligible Conditions
  • Pain
  • Opioid Use Disorder
  • Low Testosterone

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been taking strong painkillers called opioids for 6 months or longer.
Select...
You have long-term pain in your back that is not related to cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
Secondary outcome measures
Algometer-induced Pressure Pain
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)
Ice Water-induced Cold Pain and Its After-sensation
+4 more

Side effects data

From 2017 Phase 1 trial • 105 Patients • NCT01378299
9%
high hematocrit
4%
pyschiatric ilness
3%
arthroplasty
3%
osteoarthritis
3%
laceration
2%
excision of bone spur
2%
stroke
2%
coronary stent
2%
myocardial infarction
2%
diverticulitis
1%
infection of an appendectomy wound
1%
knee replacement surgery
1%
atypical chest pain
1%
cellulitis
1%
knee replacement
1%
abscess
1%
appendicitis
1%
GI tract perforation
1%
knee arthroscopy
1%
new-onset atrial fibrillation
1%
Congestive heart failure
1%
infected appendectomy wound
1%
infected spider bite
1%
shingles
1%
hemochromatosis
1%
upper respiratory infection
1%
dyspnea
1%
lung carcinoma
1%
priapism
1%
mastitis
1%
alopecia
1%
acne
1%
irritability
1%
depression
1%
headache
1%
ingrown toenail
1%
heel pain
1%
vertebral fracture
1%
sleep apnea
1%
retinal injury
1%
prostate enlargement
1%
mood swings
1%
foot pain
1%
heartburn
1%
back pain
1%
gallstones
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1: Testosterone Cypionate

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TestosteroneExperimental Treatment1 Intervention
Weekly intramuscular administration at a dose of 3 mg
Group II: PlaceboPlacebo Group1 Intervention
Weekly intramuscular administration of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved

Find a site

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,545 Previous Clinical Trials
11,380,035 Total Patients Enrolled
15 Trials studying Pain
1,311 Patients Enrolled for Pain
National Institutes of Health (NIH)NIH
2,611 Previous Clinical Trials
6,804,850 Total Patients Enrolled
13 Trials studying Pain
4,304 Patients Enrolled for Pain

Media Library

Testosterone Cypionate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04895306 — Phase 2
Pain Research Study Groups: Testosterone, Placebo
Pain Clinical Trial 2023: Testosterone Cypionate Highlights & Side Effects. Trial Name: NCT04895306 — Phase 2
Testosterone Cypionate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895306 — Phase 2
Pain Patient Testimony for trial: Trial Name: NCT04895306 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical experiment currently accepting participants?

"Affirmative. The data hosted on clinicaltrials.gov indicates that the search for trial participants is ongoing, with this study having been posted on April 1st 2022 and most recently updated a month later."

Answered by AI

For what medical purposes is Testosterone Cypionate regularly prescribed?

"Testosterone Cypionate is usually prescribed to treat hypogonadotropic hypogonadism, but it's also proven effective in cases of orchidectomy, orchitis and post-menopausal women between 1 - 5 years."

Answered by AI

Has the United States Food and Drug Administration sanctioned Testosterone Cypionate?

"Our team at Power assigned Testosterone Cypionate a safety score of 2, as Phase 2 trials have demonstrated that it is safe but efficacy has yet to be proven."

Answered by AI

How many participants have been recruited for this medical research?

"Affirmative, clinicaltrials.gov reveals that this medical study is actively recruiting participants. It was first announced on April 1st 2022 and the requirements were last amended on April 26th 2022. The research requires 40 patients to be recruited from one site."

Answered by AI

Have there been prior investigations into Testosterone Cypionate?

"Currently, 29 separate clinical trials are underway assessing the efficacy of Testosterone Cypionate. 5 of these studies have reached Phase 3 status and 124 locations across the United States offer their services for this medication's research. The majority of sites researching testosterone cypionate reside in Houston, Texas."

Answered by AI

Who else is applying?

What state do they live in?
New York
Washington
Nevada
Other
How old are they?
18 - 65
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried things that haven't worked. My *** drive lately hasn't been low and I have been feeling lethargic at times .
Patient
I was from the Boston area and live in Las Vegas. I am coming to Boston the week of July 27. If I could I would like to enter since I have chronic back pain and low testosterone.
Patient
Recent research and studies
clinicaltrials.govStudy
Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
Grace Huang 2022. "Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04895306.
~9 spots leftby Mar 2024
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