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Hormone Therapy

Testosterone Therapy for Pain in Postmenopausal Women

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
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.

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

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 more

Side effects data

From 2024 Phase 2 trial • 36 Patients • NCT03516812
58%
Fatigue
50%
Nausea
36%
Pain
22%
Constipation
19%
Anemia
19%
Anorexia
17%
Vomiting
14%
Dysgeusia
11%
Creatinine increase
11%
Diarrhea
8%
Nocturia
8%
Dizziness or Lightheadedness
8%
Weight loss
8%
Cough
6%
Insomnia
6%
Edema
6%
Hypercalcemia
6%
Abdominal pain
6%
Memory impairment
6%
Thromboembolic event
6%
Urinary retention
3%
Stroke
3%
Subdural hematoma
3%
Myocardial infarction
3%
Rib fracture
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

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,490,995 Total Patients Enrolled
15 Trials studying Pain
1,326 Patients Enrolled for Pain
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,471 Total Patients Enrolled
14 Trials studying Pain
4,379 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
~9 spots leftby Apr 2025
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