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Trial record 38 of 2104 for:    ESTRADIOL

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 20, 2016
First Posted Date  ICMJE August 9, 2016
Last Update Posted Date September 6, 2019
Study Start Date  ICMJE April 2016
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
19 point validated Female Function Index. [ Time Frame: Baseline then change over time at week 4,8,12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02859285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
36 point RAND health survey. [ Time Frame: Baseline then change over time at week 4,8,12. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
Official Title  ICMJE Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Hypoactive Sexual Desire Disorder
Intervention  ICMJE
  • Other: Placebo vulvar cream
  • Other: Estradiol vulvar cream
Study Arms  ICMJE
  • 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.

    Intervention: 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.

    Intervention: Other: Placebo vulvar cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 3, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 18, 2019
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02859285
Other Study ID Numbers  ICMJE IRB # 15-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Deb Ketterhagen, ProHealth Care, Inc
Study Sponsor  ICMJE ProHealth Care, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sarit Aschkenazi, MD ProHealth Care, Inc
PRS Account ProHealth Care, Inc
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP