18 and older, female only, with Arthralgia or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3Primary· From baseline to 3 months
The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Group
Value
95% CI
Arm II (Placebo)
-1.9
± 2.5
Arm I (Testosterone)
-2.0
± 2.5
Improvement in BPI Average Pain From Baseline to Month 3Primary· Up to 3 months
"2. Was there an improvement in BPI Average Pain from baseline to month 3?"
Group
Value
95% CI
Arm II (Placebo)
55
Arm I (Testosterone)
45
Arm II (Placebo)
49
Arm I (Testosterone)
59
Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain ScorePrimary· Baseline and 6 months
Change in BPI Average Change from Baseline Pain Score to Month Six Average Pain Score. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Group
Value
95% CI
Arm II (Placebo)
-2.2
± 2.7
Arm I (Testosterone)
-1.9
± 2.2
Change in BPI Average Pain From Baseline to Month 1-6Primary· Baseline and months 1-6
Change in BPI Average Pain from baseline to month 1-6. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
From baseline to month 1
Group
Value
95% CI
Arm II (Placebo)
-1.2
± 2.2
Arm I (Testosterone)
-1.7
± 2.1
From baseline to month 2
Group
Value
95% CI
Arm II (Placebo)
-1.9
± 2.3
Arm I (Testosterone)
-1.9
± 2.2
From baseline to month 3
Group
Value
95% CI
Arm II (Placebo)
-1.9
± 2.5
Arm I (Testosterone)
-2.0
± 2.5
From baseline to month 4
Group
Value
95% CI
Arm II (Placebo)
-2.1
± 2.5
Arm I (Testosterone)
-2.4
± 2.5
From baseline to month 5
Group
Value
95% CI
Arm II (Placebo)
-2.1
± 2.7
Arm I (Testosterone)
-2.0
± 2.6
From baseline to month 6
Group
Value
95% CI
Arm II (Placebo)
-2.2
± 2.8
Arm I (Testosterone)
-1.9
± 2.2
Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to TreatmentSecondary· Up to 6 months
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
grade 3
Group
Value
95% CI
Arm II (Placebo)
4
Arm I (Testosterone)
8
grade 4
Group
Value
95% CI
Arm II (Placebo)
1
Arm I (Testosterone)
1
Number of Patients Who Reported Alopecia Using CTCAE 4.0Secondary· Up to 6 months
The number of patients who reported alopecia using CTCAE 4.0 is reported below for each arm.
Group
Value
95% CI
Arm II (Placebo)
0
Arm I (Testosterone)
0
Number of Patients Who Reported Acne Using CTCAE 4.0Secondary· Up to 6 months
The number of patients who reported acne using CTCAE 4.0 is reported below for each arm.
Group
Value
95% CI
Arm II (Placebo)
0
Arm I (Testosterone)
0
Number of Patients Who Reported Hirsutism Using CTCAE 4.0Secondary· Up to 6 months
The number of patients who reported hirsutism using CTCAE 4.0 is reported below for each arm by grade.
Group
Value
95% CI
Arm II (Placebo)
94
Arm I (Testosterone)
87
Arm II (Placebo)
7
Arm I (Testosterone)
10
Arm II (Placebo)
0
Arm I (Testosterone)
3
Change in Hot Flash Frequency From Baseline to Week 8Secondary· baseline and week 8
Change in hot flash frequency from baseline to week 8. Hot flash frequency is a count of the number of hot flashes per day and is a number from 0 to infinity. Higher values are worse.
Group
Value
95% CI
Arm II (Placebo)
-10.9
± 20.6
Arm I (Testosterone)
-11.4
± 19.3
The Change of Libido From Baseline to Month 3 as Measured by the MENQOLSecondary· baseline and month 3
Change in how bothered are you by decreased sex drive from baseline to month 3. This is assessed using one question off of the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks "How bothered are you by a decrease in your sexual drive". This is collected on a scale ranging from 0=Not at all bothered to 6=Extremely bothered, with higher values being worse.
Group
Value
95% CI
Arm II (Placebo)
-0.5
± 2.1
Arm I (Testosterone)
-1.3
± 2.4
The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL "How Bothered Are You by Hot Flashes"Secondary· baseline and month 3
The change of menopause specific quality of life from baseline to month 3 as measured by MENQOL "how bothered are you by Hot Flashes". This is one question from the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks "How bothered are you by hot flashes or flushes". This is collected on a scale ranging from 0=Not at all bothered t 6=Extremely bothered, with higher values being worse.
Group
Value
95% CI
Arm II (Placebo)
-1.4
± 2.3
Arm I (Testosterone)
-1.4
± 2.4
Change in BPI Worst Pain From Baseline to Month 3Secondary· baseline and month 3
Change in BPI Worst Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Group
Value
95% CI
Arm II (Placebo)
-2.5
± 2.7
Arm I (Testosterone)
-2.4
± 2.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are assessed ≤ 30 days prior to registration and at the end of Months 3 and 6.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05703178 — Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology
Last refreshed: 28 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01573442.