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Hormone Therapy
Testosterone Therapy for Pain in Postmenopausal Women
Boston, MA
Phase 2
Recruiting
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
Must not have
History of breast or endometrial cancer
Estrogen therapy in the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
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.
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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.
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I have long-term back pain not caused by cancer.
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My endometrial thickness is less than 4 mm.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had breast or endometrial cancer in the past.
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I have taken estrogen therapy in the last 3 months.
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My HbA1c level is above 9%, and I am not on insulin therapy.
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My BMI is over 40.
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I have heart failure that is not well-managed.
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I have a genetic condition that causes blood clots.
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I have been diagnosed with bipolar disorder or schizophrenia.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
Secondary study objectives
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 2024 Phase 2 trial • 36 Patients • NCT0351681258%
Fatigue
50%
Nausea
36%
Pain
22%
Constipation
19%
Anemia
19%
Anorexia
17%
Vomiting
14%
Dysgeusia
11%
Creatinine increase
11%
Diarrhea
8%
Dizziness or Lightheadedness
8%
Cough
8%
Weight loss
8%
Nocturia
6%
Hypercalcemia
6%
Insomnia
6%
Memory impairment
6%
Thromboembolic event
6%
Abdominal pain
6%
Edema
6%
Urinary retention
3%
Subdural hematoma
3%
Myocardial infarction
3%
Rib fracture
3%
Stroke
3%
Cord compression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Olaparib, Testosterone Enanthate or 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 2
~150
Find a Location
Closest Location:Brigham and Women's Hospital· Boston, MA
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,692 Previous Clinical Trials
14,788,084 Total Patients Enrolled
16 Trials studying Pain
1,366 Patients Enrolled for Pain
National Institutes of Health (NIH)NIH
2,893 Previous Clinical Trials
8,051,903 Total Patients Enrolled
17 Trials studying Pain
4,662 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