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

NCT ID: NCT04895306

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Pain Opioid Use Androgen Deficiency Back Pain

Keywords

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Opioid Use Pain Women Testosterone Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Testosterone

Weekly intramuscular administration at a dose of 3 mg

Group Type EXPERIMENTAL

Testosterone Cypionate

Intervention Type DRUG

Weekly intramuscular administration of testosterone at a dose of 3 mg

Placebo

Weekly intramuscular administration of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Weekly intramuscular administration of Placebo

Interventions

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Testosterone Cypionate

Weekly intramuscular administration of testosterone at a dose of 3 mg

Intervention Type DRUG

Placebo

Weekly intramuscular administration of Placebo

Intervention Type DRUG

Other Intervention Names

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testosterone

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shehzad Basaria, M.D.

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shehzad Basaria, M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2021P001447

Identifier Type: -

Identifier Source: org_study_id