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Hormone Therapy
Testosterone Therapy for Pain in Postmenopausal Women
Phase 2
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women, age 60 years and older
Chronic non-cancer back pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
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.
Who is the study for?
This trial is for postmenopausal women over 60 with chronic back pain who have been on opioids for at least 6 months and show low testosterone levels. They must have a normal mammogram, appropriate endometrial thickness, and be able to consent. Women with a history of certain cancers, severe obesity, recent heart issues or strokes, specific blood conditions or kidney dysfunction are not eligible.Check my eligibility
What is being tested?
The TRAPP Trial is testing if testosterone replacement (using Testosterone Cypionate) can better improve pain perception, tolerance, sexual function, physical ability and life quality in these women compared to a placebo.See study design
What are the potential side effects?
Potential side effects from Testosterone Cypionate may include acne or oily skin, hair loss/thinning hair growth on the face/body; mood swings; increased red blood cell count which could lead to complications such as clots; changes in cholesterol levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 60 or older.
Select...
I have long-term back pain not caused by cancer.
Select...
My endometrial thickness is less than 4 mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
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 moreSide effects data
From 2017 Phase 1 trial • 105 Patients • NCT013782999%
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%
irritability
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%
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
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 Cypionate
2011
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,837 Total Patients Enrolled
15 Trials studying Pain
1,326 Patients Enrolled for Pain
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,548 Total Patients Enrolled
14 Trials studying Pain
4,379 Patients Enrolled for Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack, stroke, or any heart surgery in the last 3 months.I have had breast or endometrial cancer in the past.My BMI is over 40.I have long-term back pain not caused by cancer.I haven't used testosterone, spironolactone, finasteride, or ketoconazole in the last 3 months.I am a woman aged 60 or older.My endometrial thickness is less than 4 mm.I have taken estrogen therapy in the last 3 months.My HbA1c level is above 9%, and I am not on insulin therapy.I have a genetic condition that causes blood clots.I have heart failure that is not well-managed.I have been diagnosed with bipolar disorder or schizophrenia.I have been using opioid painkillers for at least 6 months.I have long-term back pain not caused by cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Testosterone
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 .
PatientReceived no prior treatments
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.
PatientReceived 2+ prior treatments
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