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Completed

NCT Number: NCT02859285

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

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.

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Key information

Conditions

Hypoactive Sexual Desire Disorder Behavior Mental Disorders Orgasm Sexual Behavior Sexual Dysfunctions, Psychological

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Waukesa Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo vulvar cream

Other

Estradiol vulvar cream

Other

Primary outcomes

  1. 19 point validated Female Function Index.

    Time frame: Baseline then change over time at week 4,8,12

Secondary outcomes

  1. 36 point RAND health survey.

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

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

ProHealth Care, Inc

Other

Registry information

Official study title

Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Aug 9, 2016
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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