VaginitisPhase 1/2NCT01122342
Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.
A Phase 1/2 study testing Testosterone propionate in people with Vaginitis and Dyspareunia, run by University of Vermont at 2 sites in United States.
Trial summary
Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia. These can significantly affect women's comfort, sexuality and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginitis, Dyspareunia, Breast Neoplasms
- What is being tested?
- Testosterone propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2006to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed breast cancer (any stage).
- Currently be using an aromatase inhibitor (anastrazole, exemestane or letrozole) for primary or adjuvant breast cancer treatment.
- Must have complaints of vaginal itching, vaginal dryness and/or dyspareunia.
- Not undergoing active chemotherapeutic or radiotherapeutic treatment
- Age >18 years
- Life expectancy of greater than 2 months.
Show all 9Show fewer
- CALGB (ZUBROD) performance status <3.
- Post-menopausal - defined by absence of menses for at least 12 months and/or an FSH >25. Not post-menopausal as a function of medications intended to suppress ovarian function, such as gonadotropin releasing hormone agonists. Surgically post-menopausal subject eligible.
- The effects of topical testosterone cream on the developing human fetus at the recommended therapeutic dose are unknown. For this study only post-menopausal women are included and all women of child-bearing potential are excluded. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- Patients who have not recovered from adverse events due to chemotherapeutic agents administered more than 4 weeks earlier.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to testosterone or the emollient delivery cream used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women and women who are breast-feeding are excluded from this study because it is limited to post-menopausal women.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fletcher Allen Health Care, University of Vermont
Burlington, Vermont, 05401
Memorial Hospital of Rhode Island,
Pawtucket, Rhode Island, 02860
About this study
Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia. These can significantly affect women's comfort, sexuality and quality of life.
Treatment for this condition includes estrogen given in pill form, commonly known as hormone replacement therapy and local estrogen treatments, such as vaginal estrogen creams and topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women with breast cancer. Some providers also feel that women who are taking aromatase inhibitors for their breast cancer should also not use local estrogens as several small studies suggest that these treatments might effect estrogen levels and thus might change how effective the aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there symptoms may not be well controlled with other treatments.
Read more
The investigators hypothesize that a vaginal testosterone cream might be a safe and effective alternative treatment for these women. This small study is intended to test the hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and pain with intercourse.
The investigators will enroll women in the trial who are taking an aromatase inhibitor and have the symptoms mentioned above. They will receive a testosterone cream which will be applied vaginally once a day for 28 days. If good results are found with a prespecified dose of testosterone, a lower dose will be tested in the next group of women enrolled.
Read the detailed description
Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin, usually due to a decreased estrogen state - such as menopause. Symptoms of atrophic vaginitis include vaginal itching, vaginal discomfort and dyspareunia and can significantly affect women's comfort, sexuality and quality of life.
Treatment for this condition includes estrogen given in pill form, commonly known as hormone replacement therapy and local estrogen treatments, such as vaginal estrogen creams and topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women with breast cancer. Some providers also feel that women who are taking aromatase inhibitors for their breast cancer should also not use local estrogens as several small studies suggest that these treatments might effect estrogen levels and thus might change how effective the aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there symptoms may not be well controlled with other treatments.
The investigators hypothesize that a vaginal testosterone cream might be a safe and effective alternative treatment for these women. This small study is intended to test the hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and pain with intercourse.
The investigators will enroll women in the trial who are taking an aromatase inhibitor and have the symptoms mentioned above. They will receive a testosterone cream which will be applied vaginally once a day for 28 days. If good results are found with a prespecified dose of testosterone, a lower dose will be tested in the next group of women enrolled.
Objectives:
PRIMARY OBJECTIVE:
1.1. Does topical testosterone cream affect serum estradiol levels in women taking aromatase inhibitors for breast cancer?
SECONDARY OBJECTIVES:
1.2. Can atrophic vaginitis and resultant symptoms of vaginal dryness, itching and dyspareunia in women taking aromatase inhibitors for the treatment of breast cancer be improved with a topical testosterone cream?
1.3. Does topical testosterone cream affect physical findings, pH and cytologic changes in atrophic vaginitis?
Schema:
Intervention - Subjects will apply a testosterone cream to the vaginal area daily for one month (28 days).
Evaluation - Before and after the study intervention participants will have testosterone and high-sensitivity estradiol tested. They will complete a questionnaire on symptoms of atrophic vaginitis and have a gynecologic examination (with visual, speculum, pH and sample of vaginal epithelial cells.)
Endpoints - Serum estradiol levels Improvement in symptoms of atrophic vaginitis, as measured by questionnaire. Atrophic vaginitis as measured by gynecological examination (including pH and cytology to assess maturation index).
- Conditions
- Vaginitis, Dyspareunia, Breast Neoplasms
- Being tested
- Testosterone propionate
- Keywords
- Testosterone, Vaginal administration, Aromatase inhibitors
- Medical subject headings
- Vaginitis, Dyspareunia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone propionateDrug
Also called Testosterone cream,, topical testosterone,, vaginal testosterone
Testosterone USP micronized powder at a dose of 1mg/gr will be made into a paste with polysorbate 80 NF liquid and will be placed in an emollient cream base. A calibrated applicator will be supplied to measure out doses containing 300mcg of testosterone for daily application. The cream will be applied daily for 28 days. As above if safety and efficacy endpoints are met at this dose a lower dose (150mcg) will be used and if in tun this meets safety and efficacy endpoints a lower dose (75mcg) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Testosterone | Experimental | Daily application of vaginal testosterone for 28 days. Receives: Drug: Testosterone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum estradiol levels
Will evaluate if serum estradiol levels, measured with a high sensitivity assay, increase in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.
Measured: 28 days
Secondary outcomes (3)
Symptoms of vaginal atrophy
Will evaluate if symptoms of atrophic vaginitis measured on a symptoms questionnaire impove in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.
Measured: 28 days
Clinical signs of vaginal atrophy.
Will evaluate if clinical signs of vaginal atrophy on gynecologic examination decrease in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.
Measured: 28 days
pathologic measures of atrophic vaginitis
Will evaluate if pathologic measures of atrophic vaginitis including maturation index and vaginal pH change in women on aromatase inhibitos for breast cancer after study intervention of 28 days of vaginal testosterone treatment.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startDec 2006
- Primary completionDec 2010 (estimated)
- Study completionJan 2011 (estimated)
Why it stopped: Evaluating outcomes of current subjects pre further enrollment/dose reduction.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Investigators
- Sabrina M Witherby, MD, Principal investigator, Memorial Hospital of Rhode Island, Warren Alpert School od Medicine at Brown UniversityHyman Muss, MD, Principal investigator, University of North CarolinaMarie Wood, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122342
- Sponsor's protocol ID
- V0606
- Status last verified
- May 2010
- First submitted
- 12 May 2010
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.
- ClinicalTrials.gov ID
- NCT01122342
- Acronym / sponsor ID
- V0606
- Conditions
- Vaginitis, Dyspareunia, Breast Neoplasms
- Keywords
- Testosterone, Vaginal administration, Aromatase inhibitors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Evaluating outcomes of current subjects pre further enrollment/dose reduction.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia. These can significantly affect women's comfort, sexuality and quality of life.
Treatment for this condition includes estrogen given in pill form, commonly known as hormone replacement therapy and local estrogen treatments, such as vaginal estrogen creams and topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women with breast cancer. Some providers also feel that women who are taking aromatase inhibitors for their breast cancer should also not use local estrogens as several small studies suggest that these treatments might effect estrogen levels and thus might change how effective the aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there symptoms may not be well controlled with other treatments.
The investigators hypothesize that a vaginal testosterone cream might be a safe and effective alternative treatment for these women. This small study is intended to test the hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and pain with intercourse.
The investigators will enroll women in the trial who are taking an aromatase inhibitor and have the symptoms mentioned above. They will receive a testosterone cream which will be applied vaginally once a day for 28 days. If good results are found with a prespecified dose of testosterone, a lower dose will be tested in the next group of women enrolled.
Detailed description
Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin, usually due to a decreased estrogen state - such as menopause. Symptoms of atrophic vaginitis include vaginal itching, vaginal discomfort and dyspareunia and can significantly affect women's comfort, sexuality and quality of life.
Treatment for this condition includes estrogen given in pill form, commonly known as hormone replacement therapy and local estrogen treatments, such as vaginal estrogen creams and topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women with breast cancer. Some providers also feel that women who are taking aromatase inhibitors for their breast cancer should also not use local estrogens as several small studies suggest that these treatments might effect estrogen levels and thus might change how effective the aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there symptoms may not be well controlled with other treatments.
The investigators hypothesize that a vaginal testosterone cream might be a safe and effective alternative treatment for these women. This small study is intended to test the hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and pain with intercourse.
The investigators will enroll women in the trial who are taking an aromatase inhibitor and have the symptoms mentioned above. They will receive a testosterone cream which will be applied vaginally once a day for 28 days. If good results are found with a prespecified dose of testosterone, a lower dose will be tested in the next group of women enrolled.
Objectives:
PRIMARY OBJECTIVE:
1.1. Does topical testosterone cream affect serum estradiol levels in women taking aromatase inhibitors for breast cancer?
SECONDARY OBJECTIVES:
1.2. Can atrophic vaginitis and resultant symptoms of vaginal dryness, itching and dyspareunia in women taking aromatase inhibitors for the treatment of breast cancer be improved with a topical testosterone cream?
1.3. Does topical testosterone cream affect physical findings, pH and cytologic changes in atrophic vaginitis?
Schema:
Intervention - Subjects will apply a testosterone cream to the vaginal area daily for one month (28 days).
Evaluation - Before and after the study intervention participants will have testosterone and high-sensitivity estradiol tested. They will complete a questionnaire on symptoms of atrophic vaginitis and have a gynecologic examination (with visual, speculum, pH and sample of vaginal epithelial cells.)
Endpoints - Serum estradiol levels Improvement in symptoms of atrophic vaginitis, as measured by questionnaire. Atrophic vaginitis as measured by gynecological examination (including pH and cytology to assess maturation index).
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: Testosterone propionateDaily application of vaginal testosterone for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed breast cancer (any stage).
- Currently be using an aromatase inhibitor (anastrazole, exemestane or letrozole) for primary or adjuvant breast cancer treatment.
- Must have complaints of vaginal itching, vaginal dryness and/or dyspareunia.
- Not undergoing active chemotherapeutic or radiotherapeutic treatment
- Age >18 years
Key exclusion criteria (4 listed)
- Patients who have not recovered from adverse events due to chemotherapeutic agents administered more than 4 weeks earlier.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to testosterone or the emollient delivery cream used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women and women who are breast-feeding are excluded from this study because it is limited to post-menopausal women.
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 propionateAlso: Testosterone cream,, topical testosterone,, vaginal testosteroneTestosterone USP micronized powder at a dose of 1mg/gr will be made into a paste with polysorbate 80 NF liquid and will be placed in an emollient cream base. A calibrated applicator will be supplied to measure out doses containing 300mcg of testosterone for daily application. The cream will be applied daily for 28 days. As above if safety and efficacy endpoints are met at this dose a lower dose (150mcg) will be used and if in tun this meets safety and efficacy endpoints a lower dose (75mcg) will be used. | Drug | Vaginal Testosterone |
Primary outcome
Serum estradiol levels
Time frame: 28 days
Will evaluate if serum estradiol levels, measured with a high sensitivity assay, increase in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.
3 secondary outcomes
Symptoms of vaginal atrophy
Time frame: 28 days
Clinical signs of vaginal atrophy.
Time frame: 28 days
pathologic measures of atrophic vaginitis
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2010.
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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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.
Sabrina M Witherby, MD principal investigator
Memorial Hospital of Rhode Island, Warren Alpert School od Medicine at Brown University
Hyman Muss, MD principal investigator
University of North Carolina
Marie Wood, MD principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Testosterone propionate in people with Vaginitis and Dyspareunia, run by University of Vermont at 2 sites 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 9 inclusion and 4 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: paused, as of the sponsor's last update on 13 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Serum estradiol levels (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2010.