PainPhase 2NCT04895306
Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)
A Phase 2 study testing Testosterone Cypionate in people with Pain and Opioid Use, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Pain, Opioid Use, Androgen Deficiency
- What is being tested?
- Testosterone Cypionate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 27 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use
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.
Read the detailed 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.
- Conditions
- Pain, Opioid Use, Androgen Deficiency, Back Pain
- Being tested
- Testosterone Cypionate, Placebo
- Keywords
- Opioid Use, Pain, Women, Testosterone, Back Pain
- Medical subject headings
- Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone CypionateDrug
Also called testosterone
Weekly intramuscular administration of testosterone at a dose of 3 mg
PlaceboDrug
Weekly intramuscular administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Weekly intramuscular administration at a dose of 3 mg Receives: Drug: Testosterone Cypionate |
| Placebo | Placebo comparator | Weekly intramuscular administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life.
Measured: 3 months
Secondary outcomes (7)
Algometer-induced Pressure Pain
A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.
Measured: 3 months
Weighted Pinprick Stimulator-induced Mechanical Pain
Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain
Measured: 3 months
Ice Water-induced Cold Pain and Its After-sensation
Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.
Measured: 3 months
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)
The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL.
Measured: 3 months
Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
The PANAS affectivity balance scale includes 10 questions evaluating positive and negative affect.
Measured: 3 months
Physical function, assessed using the 6-minute walk test (6-MWT)
Subjects will be asked to walk for 6 minutes at a comfortable pace on a premeasured flat surface; gait speed will be calculated by the distance walked (m) in 6 minutes. The 6-minute walk test (6-MWT) is an objective test of physical function validated in older adults and in women with chronic low back pain.
Measured: 3 months
Sexual Function assessed by the Female Sexual Distress Scale (FSDS)
For this 13-item questionnaire, women rate each item in terms of frequency from 0 (never) to 4 (always). Items are summed to create a total score ranging from 0 to 52, with higher scores indicating more sexually related distress
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start15 Nov 2022
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Shehzad Basaria, M.D., Brigham and Women's Hospital
- Investigators
- Shehzad Basaria, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895306
- Sponsor's protocol ID
- 2021P001447
- Status last verified
- Apr 2026
- First submitted
- 17 May 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Testosterone as a Novel Anti-Nociceptive Agent in Women With Chronic Pain and Opioid Use
- ClinicalTrials.gov ID
- NCT04895306
- Acronym / sponsor ID
- 2021P001447
- Conditions
- Pain, Opioid Use, Androgen Deficiency, Back Pain
- Keywords
- Opioid Use, Pain, Women, Testosterone, Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Experimental | Drug: Testosterone CypionateWeekly intramuscular administration at a dose of 3 mg |
| Placebo | Placebo comparator | Drug: PlaceboWeekly intramuscular administration of placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone CypionateAlso: testosteroneWeekly intramuscular administration of testosterone at a dose of 3 mg | Drug | Testosterone |
| PlaceboWeekly intramuscular administration of Placebo | Drug | Placebo |
Primary outcome
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire
Time frame: 3 months
The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life.
7 secondary outcomes
Algometer-induced Pressure Pain
Time frame: 3 months
Weighted Pinprick Stimulator-induced Mechanical Pain
Time frame: 3 months
Ice Water-induced Cold Pain and Its After-sensation
Time frame: 3 months
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)
Time frame: 3 months
Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale
Time frame: 3 months
Physical function, assessed using the 6-minute walk test (6-MWT)
Time frame: 3 months
Sexual Function assessed by the Female Sexual Distress Scale (FSDS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shehzad Basaria, M.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone Cypionate in people with Pain and Opioid Use, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.