Clinical trial NCT04895306: Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
Official title: Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pain
Opioid Use
Androgen Deficiency
Back Pain
Keywords: Opioid Use
Pain
Women
Testosterone
Back Pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-05-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Algometer-induced Pressure Pain
timeFrame: 3 months
measure: Weighted Pinprick Stimulator-induced Mechanical Pain
timeFrame: 3 months
measure: Ice Water-induced Cold Pain and Its After-sensation
timeFrame: 3 months
measure: Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)
timeFrame: 3 months
measure: Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
timeFrame: 3 months
measure: Physical function, assessed using the 6-minute walk test (6-MWT)
timeFrame: 3 months
measure: Sexual Function assessed by the Female Sexual Distress Scale (FSDS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shehzad Basaria, M.D.
role: PRINCIPAL_INVESTIGATOR
References: