Back to resultsA Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
Primary Purpose
Hypoactive Sexual Desire Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo vulvar cream
Estradiol vulvar cream
Sponsored by
About this trial
This is an interventional other trial for Hypoactive Sexual Desire Disorder focused on measuring Arousal, Orgasm, Clitoral, Estradiol, Post Menopausal
Eligibility Criteria
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
Sites / Locations
- Waukesa Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Estradiol vulvar cream
Placebo cream
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
19 point validated Female Function Index.
Secondary Outcome Measures
36 point RAND health survey.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02859285
Brief Title
A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
Official Title
Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProHealth Care, Inc
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
Arousal, Orgasm, Clitoral, Estradiol, Post Menopausal
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Estradiol vulvar cream
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo cream
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo vulvar cream
Intervention Type
Other
Intervention Name(s)
Estradiol vulvar cream
Primary Outcome Measure Information:
Title
19 point validated Female Function Index.
Time Frame
Baseline then change over time at week 4,8,12
Secondary Outcome Measure Information:
Title
36 point RAND health survey.
Time Frame
Baseline then change over time at week 4,8,12.
Other Pre-specified Outcome Measures:
Title
10 point Likert scale
Description
Visual Analog Scale to measure improvement in libido, arousal and orgasm.
Time Frame
Baseline then change over time at week 4,8,12.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarit Aschkenazi, MD
Organizational Affiliation
ProHealth Care, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Waukesa Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
We'll reach out to this number within 24 hrs