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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895306
• Other study ID #: 2021P001447
• Status: Recruiting
• Phase: Phase 2
• Start date: November 16, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: Shehzad Basaria
• Phone: 617-525-9144
• Email: sbasaria[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Androgen Deficiency
• Opioid Use
• Pain

Intervention

Drug:
• Testosterone Cypionate
Weekly intramuscular administration of testosterone at a dose of 3 mg
• Placebo
Weekly intramuscular administration of Placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Weighted Pinprick Stimulator-induced Mechanical Pain	Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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