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

P

ProHealth Care, Inc

Status

Completed

Conditions

Hypoactive Sexual Desire Disorder

Treatments

Other: Estradiol vulvar cream
Other: Placebo vulvar cream

Study type

Interventional

Funder types

Other

Identifiers

NCT02859285
IRB # 15-18

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Estradiol vulvar cream
Active Comparator group
Description:
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.
Treatment:
Other: Estradiol vulvar cream
Placebo cream
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo vulvar cream

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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