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

Description

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.

Conditions

Pain, Opioid Use, Androgen Deficiency

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Pain
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2025-04-01