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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    40
  • sponsor
    Brigham and Women's Hospital
Updated on 14 May 2022
analgesics
opioid
cancer
back pain

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.

Details
Condition Pain, Opioid Use, Androgen Deficiency
Treatment Placebo, Testosterone cypionate
Clinical Study IdentifierNCT04895306
SponsorBrigham and Women's Hospital
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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