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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Opioid Use; Androgen Deficiency
• Intervention / Treatment: Drug: Testosterone Cypionate; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Grace Huang; Phone Number: 617-525-9192; Email: ghuang7@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Grace Huang; Phone Number: 617-525-9192; Email: ghuang7@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Testosterone; Weekly intramuscular administration at a dose of 3 mg	Drug: Testosterone Cypionate; Weekly intramuscular administration of testosterone at a dose of 3 mg; Other Names: testosterone
Placebo Comparator: Placebo; Weekly intramuscular administration of placebo	Drug: Placebo; Weekly intramuscular administration of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometer-induced Pressure Pain	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.	3 months
Weighted Pinprick Stimulator-induced Mechanical Pain	Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain	3 months
Ice Water-induced Cold Pain and Its After-sensation	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.	3 months
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)	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.	3 months
Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale	The PANAS affectivity balance scale includes 10 questions evaluating positive and negative affect.	3 months
Physical function, assessed using the 6-minute walk test (6-MWT)	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.	3 months
Sexual Function assessed by the Female Sexual Distress Scale (FSDS)	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	3 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: 2021P001447

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes