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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02859285

Enrollment

Registered

2016-08-09

Start date

2016-04-30

Completion date

2020-03-10

Last updated

2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Arousal, Orgasm, Clitoral, Estradiol, Post Menopausal

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.

Interventions

OTHERPlacebo vulvar cream

OTHEREstradiol vulvar cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
19 point validated Female Function Index.	Baseline then change over time at week 4,8,12

Secondary

Measure	Time frame
36 point RAND health survey.	Baseline then change over time at week 4,8,12.

Other

Measure	Time frame	Description
10 point Likert scale	Baseline then change over time at week 4,8,12.	Visual Analog Scale to measure improvement in libido, arousal and orgasm.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026