ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-15
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04895306

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women, age 60 years and older.
  2. * Chronic non-cancer back pain.
  3. * Use of opioid analgesics for at least 6 months.
  4. * Serum total testosterone \<8.7 ng/dL and/or free testosterone \<0.47 pg/mL.
  5. * Normal mammogram within the last 12 months
  6. * Endometrial thickness of \<4 mm in women with an intact uterus assessed by endometrial ultrasound.
  7. * Ability and willingness to provide informed consent.
  1. * History of breast or endometrial cancer
  2. * Estrogen therapy in the past 3 months
  3. * Baseline hematocrit \>48%.
  4. * Serum creatinine \>2.5 mg/dL.
  5. * HbA1c \>9.0%. Subjects on insulin therapy will be excluded.
  6. * BMI \>40 kg/m2.
  7. * Uncontrolled congestive heart failure.
  8. * Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within the past 3 months.
  9. * History of genetic thromboembolic disorder.
  10. * Diagnosis of bipolar disorder or schizophrenia.
  11. * Use of testosterone, spironolactone, finasteride or systemic ketoconazole in the past 3 months.

Contacts and Locations

Principal Investigator

Shehzad Basaria, M.D.
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Shehzad Basaria, M.D., PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-15
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-11-15
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Opioid Use
  • Pain
  • Women
  • Testosterone
  • Back Pain

Additional Relevant MeSH Terms

  • Pain
  • Opioid Use
  • Androgen Deficiency
  • Back Pain