NCT04895306

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Nov 2022

Longer than P75 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

May 17, 2021

Last Update Submit

April 11, 2026

Conditions

PainOpioid UseBack PainAndrogen Deficiency

Keywords

Opioid UsePainWomenTestosteroneBack Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (7)

  • Algometer-induced Pressure Pain

    3 months

  • Weighted Pinprick Stimulator-induced Mechanical Pain

    3 months

  • Ice Water-induced Cold Pain and Its After-sensation

    3 months

  • Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)

    3 months

  • Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Testosterone

EXPERIMENTAL

Weekly intramuscular administration at a dose of 3 mg

Drug: Testosterone Cypionate

Placebo

PLACEBO COMPARATOR

Weekly intramuscular administration of placebo

Drug: Placebo

Interventions

PlaceboDRUG

Weekly intramuscular administration of Placebo

Placebo
Testosterone CypionateDRUG

Weekly intramuscular administration of testosterone at a dose of 3 mg

Also known as: testosterone
Testosterone

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

PainBack Pain

Interventions

testosterone 17 beta-cypionateTestosterone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Shehzad Basaria, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

November 15, 2022

Primary Completion

March 27, 2026

Study Completion

March 27, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(1)