Breast CancerEarly Phase 1NCT01697345

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

A Early Phase 1 study testing Testosterone in people with Breast Cancer and Vaginal Dryness, run by Creighton University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older, women only
Conditions the study is for: Breast Cancer, Vaginal Dryness, Dyspareunia
What is being tested?: Testosterone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Feb 2013to May 2013
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women with breast cancer
Currently taking an aromatase inhibitor (AI)
Age > 50 years of age
Postmenopausal, or two years since last menstrual cycle
Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse
Changes in sexual health quality of life/sexual functioning since starting AI therapy

Who cannot join

The use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months
A known sensitivity to medications containing testosterone
The use of exogenous hormone replacement therapy (HRT) in the past three months, including systemic and local estrogen or testosterone therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Nebraska Cancer Specialists/Midwest Cancer Center - Legacy
Omaha, Nebraska, 68130

Other trials in United States

About this study

Official title: Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy

It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can impair sexual functioning and cause a decreased sexual health quality of life.

At the present time, there are no Food and Drug Administration (FDA) approved medications for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment options is concerning because the number of women diagnosed with breast cancer continues to increase; their longevity, also, continues to increase with the use of newer adjuvant chemotherapies. Local health care practitioners have observed that the benefits of vaginal testosterone for sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in women without breast cancer.

The purpose of this study is to evaluate the impact of using a daily compounded vaginal testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and sexual functioning.

Conditions: Breast Cancer, Vaginal Dryness, Dyspareunia, Sexual Health Quality of Life
Being tested: Testosterone
Keywords: Vaginal Testosterone, Vaginal atrophy, Female Sexual Dysfunction, Aromatase Inhibitors
Medical subject headings: Breast Neoplasms, Dyspareunia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TestosteroneDrug

Study groups in NCT01697345
Study group	Role	What they receive
Vaginal Testosterone	Experimental	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). Receives: Drug: Testosterone

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Female Sexual Function Index (FSFI) Score
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.
Measured: Baseline, 4 weeks
FSFI Desire Domain
The 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.
Measured: Baseline, 4 weeks
FSFI Arousal Domain
The 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.
Measured: Baseline, 4 weeks
FSFI Lubrication Domain
The 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.
Measured: Baseline, 4 weeks
FSFI Orgasm Domain
The 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.
Measured: Baseline, 4 weeks
FSFI Satisfaction Domain
The 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.
Measured: Baseline, 4 weeks
FSFI Pain Domain
The 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.
Measured: Baseline, 4 weeks

Secondary outcomes (1)

Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study
Measured: After 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013May 2013

First posted2 Oct 2012 (estimated)
Study startFeb 2013
Primary completionApr 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01697345
Sponsor's protocol ID: MelissaDahir
Status last verified: Dec 2013
First submitted: 26 Sep 2012
Last updated: 24 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy
ClinicalTrials.gov ID: NCT01697345
Acronym / sponsor ID: MelissaDahir
Conditions: Breast Cancer, Vaginal Dryness, Dyspareunia, Sexual Health Quality of Life
Keywords: Vaginal Testosterone, Vaginal atrophy, Female Sexual Dysfunction, Aromatase Inhibitors
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Creighton UniversityUniversity, hospital or other
Study start: Feb 2013
Primary completion: Apr 2013 (actual)
Study completion: May 2013 (actual)
First posted: 2 Oct 2012 (estimated)
Results: Posted 24 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vaginal Testosterone	Experimental	Drug: TestosteroneTestosterone 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).

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Women with breast cancer
Currently taking an aromatase inhibitor (AI)
Age > 50 years of age
Postmenopausal, or two years since last menstrual cycle
Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse

Key exclusion criteria (3 listed)

The use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months
A known sensitivity to medications containing testosterone
The use of exogenous hormone replacement therapy (HRT) in the past three months, including systemic and local estrogen or testosterone therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Testosterone	Drug	Vaginal Testosterone

Primary outcome

Total Female Sexual Function Index (FSFI) Score
Time frame: Baseline, 4 weeks
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.
FSFI Desire Domain
Time frame: Baseline, 4 weeks
The 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.
FSFI Arousal Domain
Time frame: Baseline, 4 weeks
The 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.
FSFI Lubrication Domain
Time frame: Baseline, 4 weeks
The 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.
FSFI Orgasm Domain
Time frame: Baseline, 4 weeks
The 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.
FSFI Satisfaction Domain
Time frame: Baseline, 4 weeks
The 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.
FSFI Pain Domain
Time frame: Baseline, 4 weeks
The 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.

1 secondary outcome

Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study
Time frame: After 4 weeks

Results and safety

Results posted to the registry on 24 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaginal Testosterone	13	12

Primary outcome: Total Female Sexual Function Index (FSFI) Score

Time frame: Baseline, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	FSFI Total Score (Pretest) n = 12	FSFI Total Score (Postteset) n = 12
Value	8.691 (3.803)	18.783 (7.050)

FSFI Total Score (Pretest) vs FSFI Total Score (Postteset): Mean Difference (Final Values): -10.092 (95% CI -13.928 to -6.256), p <0.0005, t-test, 2 sided

Primary outcome: FSFI Desire Domain

Time frame: Baseline, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	FSFI Desire Domain Score (Pretest) n = 12	FSFI Desire Domain Score (Posttest) n = 12
Value	1.350 (0.373)	2.650 (0.866)

FSFI Desire Domain Score (Pretest) vs FSFI Desire Domain Score (Posttest): Mean Difference (Final Values): -1.30 (95% CI -1.859 to -0.741), p <0.0005, t-test, 2 sided

Primary outcome: FSFI Arousal Domain

Time frame: Baseline, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	FSFI Arousal Domain Score (Pretest) n = 12	FSFI Arousal Domain Score (Posttest) n = 12
Value	1.200 (0.677)	2.825 (1.256)

FSFI Arousal Domain Score (Pretest) vs FSFI Arousal Domain Score (Posttest): Median Difference (Final Values): -1.625 (95% CI -2.495 to -0.755), p = 0.002, t-test, 2 sided

Primary outcome: FSFI Lubrication Domain

Time frame: Baseline, 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	FSFI Lubrication Domain Score (Pretest) n = 12	FSFI Lubrication Domain Score (Posttest) n = 12
Value	1.175 (0.620)	2.675 (1.929)

FSFI Lubrication Domain Score (Pretest) vs FSFI Lubrication Domain Score (Posttest): Mean Difference (Final Values): -1.500 (95% CI -2.692 to -0.308), p = 0.018, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaginal Testosterone	0 of 13 (0%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): Limitations of this pilot study included the narrow time frame for enrollment, the exclusion of surgically menopausal women under the age of 50, and symptoms of recurrent Gardnerella vaginalis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa A Dahir, DNP principal investigator

Creighton University

Dianne Travers-Gustafson, PhD study chair

Creighton University

Robert Langdon, MD study director

Nebraska Cancer Specialists

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Testosterone in people with Breast Cancer and Vaginal Dryness, run by Creighton University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Female Sexual Function Index (FSFI) Score (time frame: Baseline, 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01697345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.