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

NCT02859285 | Completed

• 1 other identifier: IRB # 15-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Arousal; Orgasm; Clitoral; Estradiol; Post Menopausal

Outcome Measures

Primary Outcomes (1)

• 19 point validated Female Function Index.

  Baseline then change over time at week 4,8,12

Secondary Outcomes (1)

• 36 point RAND health survey.

  Baseline then change over time at week 4,8,12.

Other Outcomes (1)

• 10 point Likert scale

  Baseline then change over time at week 4,8,12.

Study Arms (2)

Estradiol vulvar cream

ACTIVE COMPARATOR

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 cream

PLACEBO COMPARATOR

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

Interventions

Placebo vulvar cream OTHER

Placebo cream

Estradiol vulvar cream OTHER

Estradiol vulvar cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProHealth Care, Inc: lead

Study Sites (1)

Waukesa Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Orgasm

Condition Hierarchy (Ancestors)

Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Sarit Aschkenazi, MD

  ProHealth Care, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: August 9, 2016
• Study Start: April 1, 2016
• Primary Completion: March 18, 2019
• Study Completion: March 10, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (1)