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Completed

NCT Number: NCT04895306

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

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.

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Key information

Conditions

Pain Androgen Deficiency Back Pain Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone Cypionate

Drug

Weekly intramuscular administration of testosterone at a dose of 3 mg

Other names: testosterone

Placebo

Drug

Weekly intramuscular administration of Placebo

Primary outcomes

  1. Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire

    Time frame: 3 months

    The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life.

Secondary outcomes

  1. Algometer-induced Pressure Pain

    Time frame: 3 months

    A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.

  2. Weighted Pinprick Stimulator-induced Mechanical Pain

    Time frame: 3 months

    Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain

  3. Ice Water-induced Cold Pain and Its After-sensation

    Time frame: 3 months

    Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.

  4. Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)

    Time frame: 3 months

    The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL.

  5. Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale

    Time frame: 3 months

    The PANAS affectivity balance scale includes 10 questions evaluating positive and negative affect.

  6. Physical function, assessed using the 6-minute walk test (6-MWT)

    Time frame: 3 months

    Subjects will be asked to walk for 6 minutes at a comfortable pace on a premeasured flat surface; gait speed will be calculated by the distance walked (m) in 6 minutes. The 6-minute walk test (6-MWT) is an objective test of physical function validated in older adults and in women with chronic low back pain.

  7. Sexual Function assessed by the Female Sexual Distress Scale (FSDS)

    Time frame: 3 months

    For this 13-item questionnaire, women rate each item in terms of frequency from 0 (never) to 4 (always). Items are summed to create a total score ranging from 0 to 52, with higher scores indicating more sexually related distress

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 20, 2021
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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