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

Last updated: December 23, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Chronic Pain

Pain

Hypogonadism

Treatment

Placebo

Testosterone Cypionate

Clinical Study ID

NCT04895306
2021P001447
  • Ages > 60
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 byendometrial ultrasound.

  • Ability and willingness to provide informed consent.

Exclusion

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 strokewithin the past 3 months.

  • History of genetic thromboembolic disorder.

  • Diagnosis of bipolar disorder or schizophrenia.

  • Use of testosterone, spironolactone, finasteride or systemic ketoconazole in thepast 3 months.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 15, 2022
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

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