ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02859285
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : September 21, 2017
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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 31, 2018

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Contacts
Contact: Deb Ketterhagen, MSN 2629284061 debra.ketterhagen@phci.org

Locations
United States, Wisconsin
Waukesa Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Deb Ketterhagen, MSN         
Sub-Investigator: Jodi Wilde, MSN         
Sub-Investigator: Sarit Aschkenazi, MD         
Sponsors and Collaborators
ProHealth Care, Inc

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 21, 2017
Last Verified: September 2017
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:
Sexual Dysfunctions, Psychological
Mental Disorders
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female