A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream

Conditions
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Hypoactive Sexual Desire Disorder

Intervention / Treatment
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* Other: Placebo vulvar cream
* Other: Estradiol vulvar cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sexually active postmenopausal women of any age with complaint of vulvar and/or vaginal atrophy who also complain of bothersome decreased libido, and/or arousal, and/or orgasmic dysfunction Exclusion Criteria: Not sexually active with a partner or an arousal device Uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dL Uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, among those with hypertension Allergic to estradiol Contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease Spanish speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Estradiol vulvar cream<br>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. | Other: Estradiol vulvar cream<br> <br> |
| Placebo Comparator: Placebo cream<br>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. | Other: Placebo vulvar cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 19 point validated Female Function Index. |  | Baseline then change over time at week 4,8,12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 36 point RAND health survey. |  | Baseline then change over time at week 4,8,12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arousal, Orgasm, Clitoral, Estradiol, Post Menopausal