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Testosterone therapy tested as new pain relief for women on opioids

NCT ID NCT04895306

Symptom relief Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving testosterone to older women with chronic back pain and low testosterone could improve pain, physical function, and quality of life. 36 women received weekly injections of either testosterone or a placebo for several weeks. The goal was to see if testosterone could be a safe and effective way to manage pain and reduce opioid use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
testosterone cypionate (a form of testosterone)
What this could lead to
If it works, this could point toward a new way to manage chronic pain in older women and reduce reliance on opioids.
What could go wrong
This is a small, early-phase trial with only 36 participants, so results may not apply widely. Testosterone therapy can have side effects, and the benefit over placebo is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Nov 2022

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Back Pain hypogonadism opioid abuse Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Androgen deficiency Back pain Opioid use Pain

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.