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Trial record 36 of 2077 for:    ESTRADIOL

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

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ClinicalTrials.gov Identifier: NCT02859285
Recruitment Status : Active, not recruiting
First Posted : August 9, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Deb Ketterhagen, 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.

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Other: Placebo vulvar cream Other: Estradiol vulvar cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 2016
Actual Primary Completion Date : March 18, 2019
Estimated Study Completion Date : September 18, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 19 point validated Female Function Index. [ Time Frame: Baseline then change over time at week 4,8,12 ]

Secondary Outcome Measures :
  1. 36 point RAND health survey. [ Time Frame: Baseline then change over time at week 4,8,12. ]

Other Outcome Measures:
  1. 10 point Likert scale [ Time Frame: Baseline then change over time at week 4,8,12. ]
    Visual Analog Scale to measure improvement in libido, arousal and orgasm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859285


Locations
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United States, Wisconsin
Waukesa Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
ProHealth Care, Inc
Investigators
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Study Director: Sarit Aschkenazi, MD ProHealth Care, Inc

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Responsible Party: Deb Ketterhagen, Advance Practice Nurse- Women's Center, ProHealth Care, Inc
ClinicalTrials.gov Identifier: NCT02859285     History of Changes
Other Study ID Numbers: IRB # 15-18
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Deb Ketterhagen, ProHealth Care, Inc:
Arousal
Orgasm
Clitoral
Estradiol
Post Menopausal
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Sexual Dysfunctions, Psychological
Mental Disorders
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female