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

Sponsor

ProHealth Care, Inc (Other)

Overall Status

Completed

CT.gov ID

NCT02859285

Collaborator

(none)

Enrollment

Location

Arms

47.3

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder	Other: Placebo vulvar cream Other: Estradiol vulvar cream	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Mar 18, 2019

Actual Study Completion Date :

Mar 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: Estradiol vulvar cream
Placebo Comparator: Placebo 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.	Other: Placebo vulvar cream

Arm

Intervention/Treatment

Active Comparator: 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.

Other: Estradiol vulvar cream

Placebo Comparator: Placebo 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.

Other: Placebo vulvar cream

Outcome Measures

Primary Outcome Measures

19 point validated Female Function Index. [Baseline then change over time at week 4,8,12]

Secondary Outcome Measures

36 point RAND health survey. [Baseline then change over time at week 4,8,12.]

Other Outcome Measures

10 point Likert scale [Baseline then change over time at week 4,8,12.]
Visual Analog Scale to measure improvement in libido, arousal and orgasm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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
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