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The purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol vulvar cream | Active Comparator | The estradiol cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks. In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks. |
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| Placebo cream | Placebo Comparator | The placebo cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks. In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo vulvar cream | Other |
| ||
| Estradiol vulvar cream |
| Measure | Description | Time Frame |
|---|---|---|
| 19 point validated Female Function Index. | Baseline then change over time at week 4,8,12 |
| Measure | Description | Time Frame |
|---|---|---|
| 36 point RAND health survey. | Baseline then change over time at week 4,8,12. |
| Measure | Description | Time Frame |
|---|---|---|
| 10 point Likert scale | Visual Analog Scale to measure improvement in libido, arousal and orgasm. | Baseline then change over time at week 4,8,12. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarit Aschkenazi, MD | ProHealth Care, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waukesa Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D009948 | Orgasm |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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