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

Not Applicable

Completed

• Conditions: Hypoactive Sexual Desire Disorder
• Interventions: Other: Placebo vulvar cream; Other: Estradiol vulvar cream

• Registration Number: NCT02859285
• Lead Sponsor: ProHealth Care, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-09
• Primary Completion: 2019-03-18
• Status Verified: 2020-03
• Study Completion: 2020-03-10
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo cream	Placebo vulvar cream	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.
Estradiol vulvar cream	Estradiol vulvar cream	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.

Primary Outcome Measures

Name	Time	Method
19 point validated Female Function Index.	Baseline then change over time at week 4,8,12

Secondary Outcome Measures

Name	Time	Method
36 point RAND health survey.	Baseline then change over time at week 4,8,12.

Trial Locations

Locations (1)

Waukesa Memorial Hospital; 🇺🇸 Waukesha, Wisconsin, United States