Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)

Mass General Brigham

Status and phase: Active, not recruiting; Phase 2

Conditions: Back Pain; Androgen Deficiency; Opioid Use; Pain

Treatments: Drug: Testosterone Cypionate; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04895306

2021P001447

Details and patient eligibility

About

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, physical function and quality of life when compared with placebo in women with chronic back pain treated with opioids who have low testosterone.

Full description

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 3 months of treatment with testosterone or placebo in women aged 60 years or older with chronic non-cancer back pain who are taking opioid analgesics for at least 6 months and have low testosterone.

Enrollment: 40 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women, age 60 years and older.
• Chronic non-cancer back pain.
• Use of opioid analgesics for at least 6 months.
• Serum total testosterone <8.7 ng/dL and/or free testosterone <0.47 pg/mL.
• Normal mammogram within the last 12 months
• Endometrial thickness of <4 mm in women with an intact uterus assessed by endometrial ultrasound.
• Ability and willingness to provide informed consent.

Exclusion criteria

• History of breast or endometrial cancer
• Estrogen therapy in the past 3 months
• Baseline hematocrit >48%.
• Serum creatinine >2.5 mg/dL.
• HbA1c >9.0%. Subjects on insulin therapy will be excluded.
• BMI >40 kg/m2.
• Uncontrolled congestive heart failure.
• Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within the past 3 months.
• History of genetic thromboembolic disorder.
• Diagnosis of bipolar disorder or schizophrenia.
• Use of testosterone, spironolactone, finasteride or systemic ketoconazole in the past 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Testosterone

Experimental group

Description:

Weekly intramuscular administration at a dose of 3 mg

Treatment:

Drug: Testosterone Cypionate

Placebo

Placebo Comparator group

Description:

Weekly intramuscular administration of placebo

Treatment:

Drug: Placebo