Vaginal DHEA for Women After Breast Cancer

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01724242

Collaborator

(none)

Enrollment

Location

Arms

21.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Dryness Breast Cancer Urinary Incontinence Quality of Life Sexual Satisfaction	Drug: Vaginal DHEA Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal DHEA Vaginal DHEA 0.5%(6.5mg)inserted nightly	Drug: Vaginal DHEA
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Vaginal DHEA

Vaginal DHEA 0.5%(6.5mg)inserted nightly

Drug: Vaginal DHEA

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

improvement in vaginal dryness [12 weeks]

Secondary Outcome Measures

improvement in urinary incontinence [12 weeks]
improvement in sexual satisfaction [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed.