Ignite Creation Date:
2024-05-05 @ 10:30 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01122342
Status:
SUSPENDED
Last Update Posted:
2010-05-13
First Post:
2010-05-12
Brief Title:
Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer
Status:
SUSPENDED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Evaluating outcomes of current subjects pre further enrollmentdose reduction
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 womens 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
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 womens 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
11 Does topical testosterone cream affect serum estradiol levels in women taking aromatase inhibitors for breast cancer
SECONDARY OBJECTIVES
12 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
13 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
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
11 Does topical testosterone cream affect serum estradiol levels in women taking aromatase inhibitors for breast cancer
SECONDARY OBJECTIVES
12 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
13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None