A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women (NCT02859285) | Clinical Trial Compass
CompletedNot Applicable
A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
United States30 participantsStarted 2016-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ā„140 mmHg or an average diastolic blood pressure ā„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
What they're measuring
1
19 point validated Female Function Index.
Timeframe: Baseline then change over time at week 4,8,12