Trial Outcomes & Findings for Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy (NCT NCT01697345)
NCT ID: NCT01697345
Last Updated: 2014-01-24
Results Overview
The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score \< 26.5 suggests female sexual dysfunction.
COMPLETED
EARLY_PHASE1
12 participants
Baseline, 4 weeks
2014-01-24
Participant Flow
Participants were prospectively recruited from Nebraska Cancer Specialists in Omaha, NE, between January 11, 2013, and April 23, 2013.
During the first study visit, the the PI procured a vaginal swab because women with suppressed estrogen levels have an increased risk for infection. Also, in the clinical setting, the PI has observed that women who develop a yeast or bacterial infection while using vaginal testosterone frequently report symptoms of vaginal burning or irritation.
Participant milestones
| Measure |
Vaginal Testosterone
Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
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|---|---|
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Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Vaginal Testosterone
Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
Baseline characteristics by cohort
| Measure |
Vaginal Testosterone
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
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|---|---|
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Age, Continuous
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59.67 Years
STANDARD_DEVIATION 6.095 • n=99 Participants
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Sex: Female, Male
Female
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12 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Marital Status
Married
|
12 Participants
n=99 Participants
|
|
Marital Status
Not Married
|
0 Participants
n=99 Participants
|
|
Length of Marriage
0-5 years
|
1 participants
n=99 Participants
|
|
Length of Marriage
6-10 years
|
0 participants
n=99 Participants
|
|
Length of Marriage
11-15 years
|
0 participants
n=99 Participants
|
|
Length of Marriage
16-20 years
|
0 participants
n=99 Participants
|
|
Length of Marriage
21-25 years
|
5 participants
n=99 Participants
|
|
Length of Marriage
26-30 years
|
1 participants
n=99 Participants
|
|
Length of Marriage
31-35 years
|
2 participants
n=99 Participants
|
|
Length of Marriage
36-40 years
|
2 participants
n=99 Participants
|
|
Length of Marriage
41-50 years
|
0 participants
n=99 Participants
|
|
Length of Marriage
51-55 years
|
1 participants
n=99 Participants
|
|
Highest Level of Education
High school degree
|
3 Participants
n=99 Participants
|
|
Highest Level of Education
Associate's degree
|
3 Participants
n=99 Participants
|
|
Highest Level of Education
Bachelor's degree
|
4 Participants
n=99 Participants
|
|
Highest Level of Education
Master's degree
|
2 Participants
n=99 Participants
|
|
Oophorectomy
Yes
|
4 Participants
n=99 Participants
|
|
Oophorectomy
No
|
8 Participants
n=99 Participants
|
|
Estrogen-receptor (ER) Status
ER+
|
11 Participants
n=99 Participants
|
|
Estrogen-receptor (ER) Status
ER-
|
1 Participants
n=99 Participants
|
|
Progesterone-receptor (PR) Status
PR+
|
10 Participants
n=99 Participants
|
|
Progesterone-receptor (PR) Status
PR-
|
2 Participants
n=99 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) Status
HER2+
|
1 Participants
n=99 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER2) Status
HER2-
|
11 Participants
n=99 Participants
|
|
Aromatase Inhibitor
anastrozole (Arimidex)
|
11 Participants
n=99 Participants
|
|
Aromatase Inhibitor
letrozole (Femara)
|
1 Participants
n=99 Participants
|
|
Aromatase Inhibitor
exemestane (Aromasin)
|
0 Participants
n=99 Participants
|
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Vaginal Swab Test
No vaginal infection
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9 Participants
n=99 Participants
|
|
Vaginal Swab Test
Gardnerella vaginalis
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3 Participants
n=99 Participants
|
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Vaginal Swab Test
Candidiasis species
|
0 Participants
n=99 Participants
|
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Sexually Active Prior to Study
Yes
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7 Participants
n=99 Participants
|
|
Sexually Active Prior to Study
No
|
5 Participants
n=99 Participants
|
|
Sexually Active During Study
Yes
|
11 Participants
n=99 Participants
|
|
Sexually Active During Study
No
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score \< 26.5 suggests female sexual dysfunction.
Outcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
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|---|---|---|
|
Total Female Sexual Function Index (FSFI) Score
|
8.691 units on a scale
Standard Deviation 3.803
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18.783 units on a scale
Standard Deviation 7.050
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.
Outcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
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|---|---|---|
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FSFI Desire Domain
|
1.350 units on a scale
Standard Deviation 0.373
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2.650 units on a scale
Standard Deviation 0.866
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.
Outcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
|
|---|---|---|
|
FSFI Arousal Domain
|
1.200 units on a scale
Standard Deviation 0.677
|
2.825 units on a scale
Standard Deviation 1.256
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
Outcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
|
|---|---|---|
|
FSFI Lubrication Domain
|
1.175 units on a scale
Standard Deviation 0.620
|
2.675 units on a scale
Standard Deviation 1.929
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
Outcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
|
|---|---|---|
|
FSFI Orgasm Domain
|
1.733 units on a scale
Standard Deviation 1.767
|
2.933 units on a scale
Standard Deviation 2.049
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.
Outcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
|
|---|---|---|
|
FSFI Satisfaction Domain
|
2.300 units on a scale
Standard Deviation 1.311
|
4.200 units on a scale
Standard Deviation 1.293
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
Outcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
|
|---|---|---|
|
FSFI Pain Domain
|
0.933 units on a scale
Standard Deviation 0.875
|
3.500 units on a scale
Standard Deviation 2.276
|
SECONDARY outcome
Timeframe: After 4 weeksOutcome measures
| Measure |
FSFI Total Score (Pretest)
n=12 Participants
Administered to participants prior to starting vaginal testosterone therapy.
|
FSFI Total Score (Postteset)
n=12 Participants
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
|
|---|---|---|
|
Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study
|
11 participants
|
1 participants
|
Adverse Events
Vaginal Testosterone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place