Arthralgia, Breast Cancer, Hot Flashes, Musculoskeletal Complications, Sexual Dysfunction
Conditions
Keywords
hot flashes, musculoskeletal complications, sexual dysfunction, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, arthralgia, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Brief summary
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.
Detailed description
This is a randomized, placebo-controlled, phase III trial evaluating subcutaneous testosterone for the alleviation of aromatase inhibitor induced arthralgia. A parallel group design will be utilized for this two-arm study: subcutaneous testosterone vs. placebo. Patients are stratified according to baseline pain score (5-6 vs. 7-10) and age (\< 50 vs. 50-60 vs. \> 60). The primary objective is to determine whether testosterone will reduce AI-induced arthralgia and associated joint symptoms. The secondary objective is to explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia. Patients are followed up to six months as defined in the protocol.
Interventions
DRUGtestosterone
10.4 mg
OTHERplacebo
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Receiving anastrozole (1mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration and plan to continue it throughout the duration of study 3. Body Mass Index (BMI) between 18 and 35 kg/m\^2 4. Women who have undergone a total mastectomy or breast conserving surgery for primary breast cancer +/-chemo, +/-radiotherapy. 5. Must have BOTH ER and PR receptor-positive tumors and BOTH must be ≥26% positive. Alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher 6. Women who are postmenopausal by surgery, radiotherapy or presence of natural amenorrhea ≥ 12 months 7. ≥ 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor as defined in the protocol. Note: Patients may, or may not, be taking non-opioid analgesics 8. Ability to complete questionnaire(s) by themselves or with assistance 9. ECOG Performance Status (PS) 0, 1 or 2 10. Willing to provide informed written consent 11. Willing to return to an Alliance enrolling institution for follow-up 12. Willing to provide blood samples for correlative research purposes 13. Laboratory values prior to registration as defined in the protocol: 1. Creatinine ≤1.5 x ULN 2. Hemoglobin \> 11 g/dL 3. WBC \> 3.0 4. Platelet Count \> 100,000 5. SGOT (AST) ≤ 1.5 x ULN
Exclusion criteria
1. Presence of residual or recurrent cancer (locally or metastatic) 2. Diabetes mellitus or glucose intolerance, defined as a fasting glucose \>125 mg/dL 3. History of coronary artery disease (angina or myocardial infarction) 4. Patients on hormone replacement therapy (HRT) ≤ 4 weeks prior to registration. This includes the use of vaginal estrogen therapy. 5. Known hypersensitivity to any component of testosterone. 6. Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airway diseases), eye drops or local insertion (e.g. intra-articular). Note: Short duration (\< 2 weeks) of systemic corticosteroids is allowed (e.g. for chronic obstructive pulmonary disease) but not within 30 days prior to registration. 7. Receiving any other investigational agent 8. History of a deep venous thrombosis or a thromboembolism 9. Concurrent use of the aromatase inhibitor exemestane, as it is structurally similar to an androgen 10. Concurrent radiation therapy or chemotherapy 11. Current or planned use of cyclosporine, anticoagulants, oxphenbutazone, insulin, oral or injectable vitamin D doses over 4,000IU/day, or tamoxifen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score | 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. |
| Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 | 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. |
| Improvement in BPI Average Pain From Baseline to Month 3 | Up to 3 months | 2. Was there an improvement in BPI Average Pain from baseline to month 3? |
| Change in BPI Average Pain From Baseline to Month 1-6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Reported Hirsutism Using CTCAE 4.0 | Up to 6 months | The number of patients who reported hirsutism using CTCAE 4.0 is reported below for each arm by grade. |
| The Change of Libido From Baseline to Month 3 as Measured by the MENQOL | 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. |
| The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL How Bothered Are You by Hot Flashes | 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. |
| Change in BPI Worst Pain From Baseline to Month 3 | 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. |
| Change in Hot Flash Frequency From Baseline to Week 8 | 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. |
| Change in BPI Pain Right Now From Baseline to Month 3 | baseline and month 3 | Change in BPI Pain right now 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. |
| Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness) | baseline and month 3 | Change in average joint stiffness 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. |
| The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA. | baseline and month 3 | The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. Change in general activity 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. |
| Change in BPI Least Pain From Baseline to Month 3 | baseline and month 3 | Change in BPI Least 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. |
| Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment | 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. |
| Number of Patients Who Reported Alopecia Using CTCAE 4.0 | Up to 6 months | The number of patients who reported alopecia using CTCAE 4.0 is reported below for each arm. |
| Number of Patients Who Reported Acne Using CTCAE 4.0 | Up to 6 months | The number of patients who reported acne using CTCAE 4.0 is reported below for each arm. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm II (Placebo) Patients receive placebo (0.264mL) topical application daily for six months. | 104 |
| Arm I (Testosterone) Patients receive testosterone (0.264mL) topical application daily for six months. | 104 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancels | 9 | 10 |
Baseline characteristics
| Characteristic | Arm II (Placebo) | Arm I (Testosterone) | Total |
|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 9.7 | 59.9 years STANDARD_DEVIATION 8.7 | 60.0 years STANDARD_DEVIATION 9.2 |
| ECOG Performance Status 0 | 81 Participants | 81 Participants | 162 Participants |
| ECOG Performance Status 1 | 23 Participants | 20 Participants | 43 Participants |
| ECOG Performance Status 2 | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 94 Participants | 100 Participants | 194 Participants |
| Sex: Female, Male Female | 104 Participants | 104 Participants | 208 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 100 |
| other Total, other adverse events | 23 / 101 | 25 / 100 |
| serious Total, serious adverse events | 1 / 101 | 5 / 100 |
Outcome results
Primary
Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score
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.
Time frame: Baseline and 6 months
Population: Patients who completed item #3 (average) of the BPI at baseline and month 6 time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score | -2.2 score on a scale | Standard Deviation 2.7 |
| Arm I (Testosterone) | Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score | -1.9 score on a scale | Standard Deviation 2.2 |
p-value: 0.676Wilcoxon (Mann-Whitney)
Primary
Change in BPI Average Pain From Baseline to Month 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.
Time frame: Baseline and months 1-6
Population: Number analyzed below are based on patients who completed the BPI Average Pain item at baseline and specified month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 1 | -1.2 score on a scale | Standard Deviation 2.2 |
| Arm II (Placebo) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 2 | -1.9 score on a scale | Standard Deviation 2.3 |
| Arm II (Placebo) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 3 | -1.9 score on a scale | Standard Deviation 2.5 |
| Arm II (Placebo) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 4 | -2.1 score on a scale | Standard Deviation 2.5 |
| Arm II (Placebo) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 5 | -2.1 score on a scale | Standard Deviation 2.7 |
| Arm II (Placebo) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 6 | -2.2 score on a scale | Standard Deviation 2.8 |
| Arm I (Testosterone) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 5 | -2.0 score on a scale | Standard Deviation 2.6 |
| Arm I (Testosterone) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 1 | -1.7 score on a scale | Standard Deviation 2.1 |
| Arm I (Testosterone) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 4 | -2.4 score on a scale | Standard Deviation 2.5 |
| Arm I (Testosterone) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 2 | -1.9 score on a scale | Standard Deviation 2.2 |
| Arm I (Testosterone) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 6 | -1.9 score on a scale | Standard Deviation 2.2 |
| Arm I (Testosterone) | Change in BPI Average Pain From Baseline to Month 1-6 | From baseline to month 3 | -2.0 score on a scale | Standard Deviation 2.5 |
Comparison: From baseline to month 1p-value: 0.029Wilcoxon (Mann-Whitney)
Comparison: From baseline to month 2p-value: 0.8214Wilcoxon (Mann-Whitney)
Comparison: From baseline to month 3p-value: 0.4952Wilcoxon (Mann-Whitney)
Comparison: From baseline to month 4p-value: 0.5232Wilcoxon (Mann-Whitney)
Comparison: From baseline to month 5p-value: 0.5522Wilcoxon (Mann-Whitney)
Comparison: From baseline to month 6p-value: 0.7005Wilcoxon (Mann-Whitney)
Primary
Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3
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.
Time frame: From baseline to 3 months
Population: Patients who completed item #3 (average) of the BPI at baseline and month 3 time points are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 | -1.9 score on a scale | Standard Deviation 2.5 |
| Arm I (Testosterone) | Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 | -2.0 score on a scale | Standard Deviation 2.5 |
p-value: 0.4952Wilcoxon (Mann-Whitney)
Primary
Improvement in BPI Average Pain From Baseline to Month 3
2. Was there an improvement in BPI Average Pain from baseline to month 3?
Time frame: Up to 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm II (Placebo) | Improvement in BPI Average Pain From Baseline to Month 3 | No | 55 Participants |
| Arm II (Placebo) | Improvement in BPI Average Pain From Baseline to Month 3 | Yes | 49 Participants |
| Arm I (Testosterone) | Improvement in BPI Average Pain From Baseline to Month 3 | No | 45 Participants |
| Arm I (Testosterone) | Improvement in BPI Average Pain From Baseline to Month 3 | Yes | 59 Participants |
p-value: 0.2116Fisher Exact
Secondary
Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness)
Change in average joint stiffness 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.
Time frame: baseline and month 3
Population: Patients who completed the BPI item #5 on joint stiffness at baseline and month 3 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness) | -2.0 score on a scale | Standard Deviation 2.7 |
| Arm I (Testosterone) | Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness) | -2.2 score on a scale | Standard Deviation 2.9 |
p-value: 0.7694Wilcoxon (Mann-Whitney)
Secondary
Change in BPI Least Pain From Baseline to Month 3
Change in BPI Least 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.
Time frame: baseline and month 3
Population: Patients who completed the BPI Least pain item at baseline and month 3 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Change in BPI Least Pain From Baseline to Month 3 | -1.0 score on a scale | Standard Deviation 2.8 |
| Arm I (Testosterone) | Change in BPI Least Pain From Baseline to Month 3 | -1.3 score on a scale | Standard Deviation 2.3 |
p-value: 0.4335Wilcoxon (Mann-Whitney)
Secondary
Change in BPI Pain Right Now From Baseline to Month 3
Change in BPI Pain right now 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.
Time frame: baseline and month 3
Population: Patients who completed the BPI pain right now item at baseline and month 3 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Change in BPI Pain Right Now From Baseline to Month 3 | -1.6 score on a scale | Standard Deviation 3 |
| Arm I (Testosterone) | Change in BPI Pain Right Now From Baseline to Month 3 | -2.1 score on a scale | Standard Deviation 2.7 |
p-value: 0.286Wilcoxon (Mann-Whitney)
Secondary
Change in BPI Worst Pain From Baseline to 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.
Time frame: baseline and month 3
Population: Patients who complete the BPI Worst item at baseline and month 3 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Change in BPI Worst Pain From Baseline to Month 3 | -2.5 score on a scale | Standard Deviation 2.7 |
| Arm I (Testosterone) | Change in BPI Worst Pain From Baseline to Month 3 | -2.4 score on a scale | Standard Deviation 2.6 |
p-value: 0.8748Wilcoxon (Mann-Whitney)
Secondary
Change in Hot Flash Frequency From Baseline to 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.
Time frame: baseline and week 8
Population: Patients who completed the questionnaire at baseline and week 8 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Change in Hot Flash Frequency From Baseline to Week 8 | -10.9 hot flashes/day | Standard Deviation 20.6 |
| Arm I (Testosterone) | Change in Hot Flash Frequency From Baseline to Week 8 | -11.4 hot flashes/day | Standard Deviation 19.3 |
p-value: 0.8761Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment
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.
Time frame: Up to 6 months
Population: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm II (Placebo) | Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment | grade 3 | 4 Participants |
| Arm II (Placebo) | Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment | grade 4 | 1 Participants |
| Arm I (Testosterone) | Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment | grade 3 | 8 Participants |
| Arm I (Testosterone) | Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment | grade 4 | 1 Participants |
Secondary
Number of Patients Who Reported Acne Using CTCAE 4.0
The number of patients who reported acne using CTCAE 4.0 is reported below for each arm.
Time frame: Up to 6 months
Population: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm II (Placebo) | Number of Patients Who Reported Acne Using CTCAE 4.0 | 0 Participants |
| Arm I (Testosterone) | Number of Patients Who Reported Acne Using CTCAE 4.0 | 0 Participants |
Secondary
Number of Patients Who Reported Alopecia Using CTCAE 4.0
The number of patients who reported alopecia using CTCAE 4.0 is reported below for each arm.
Time frame: Up to 6 months
Population: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm II (Placebo) | Number of Patients Who Reported Alopecia Using CTCAE 4.0 | 0 Participants |
| Arm I (Testosterone) | Number of Patients Who Reported Alopecia Using CTCAE 4.0 | 0 Participants |
Secondary
Number of Patients Who Reported Hirsutism Using CTCAE 4.0
The number of patients who reported hirsutism using CTCAE 4.0 is reported below for each arm by grade.
Time frame: Up to 6 months
Population: Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm II (Placebo) | Number of Patients Who Reported Hirsutism Using CTCAE 4.0 | 0-None | 94 Participants |
| Arm II (Placebo) | Number of Patients Who Reported Hirsutism Using CTCAE 4.0 | 1-Mild | 7 Participants |
| Arm II (Placebo) | Number of Patients Who Reported Hirsutism Using CTCAE 4.0 | 2-Moderate | 0 Participants |
| Arm I (Testosterone) | Number of Patients Who Reported Hirsutism Using CTCAE 4.0 | 0-None | 87 Participants |
| Arm I (Testosterone) | Number of Patients Who Reported Hirsutism Using CTCAE 4.0 | 1-Mild | 10 Participants |
| Arm I (Testosterone) | Number of Patients Who Reported Hirsutism Using CTCAE 4.0 | 2-Moderate | 3 Participants |
p-value: 0.139Wilcoxon (Mann-Whitney)
Secondary
The Change of Libido From Baseline to Month 3 as Measured by the MENQOL
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.
Time frame: baseline and month 3
Population: Patients who completed MENQOL libido question 'how bothered are you by decreased sex drive' at baseline and month 3 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | The Change of Libido From Baseline to Month 3 as Measured by the MENQOL | -0.5 score on a scale | Standard Deviation 2.1 |
| Arm I (Testosterone) | The Change of Libido From Baseline to Month 3 as Measured by the MENQOL | -1.3 score on a scale | Standard Deviation 2.4 |
p-value: 0.0176Wilcoxon (Mann-Whitney)
Secondary
The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL How Bothered Are You by Hot Flashes
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.
Time frame: baseline and month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL How Bothered Are You by Hot Flashes | -1.4 score on a scale | Standard Deviation 2.3 |
| Arm I (Testosterone) | The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL How Bothered Are You by Hot Flashes | -1.4 score on a scale | Standard Deviation 2.4 |
p-value: 0.7077Wilcoxon (Mann-Whitney)
Secondary
The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA.
The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. Change in general activity 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.
Time frame: baseline and month 3
Population: Patients who completed the BPI item #6 at baseline and month 3 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA. | -2.1 score on a scale | Standard Deviation 3 |
| Arm I (Testosterone) | The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA. | -2.1 score on a scale | Standard Deviation 3.1 |
p-value: 0.9609Wilcoxon (Mann-Whitney)