Vaginal DHEA for Women After Breast Cancer

Phase 2

Withdrawn

• Conditions: Vaginal Dryness; Breast Cancer; Urinary Incontinence; Quality of Life; Sexual Satisfaction
• Interventions: Drug: Placebo; Drug: Vaginal DHEA

• Registration Number: NCT01724242
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-09
• Study Start: 2013-02
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Exclusion Criteria

• women using products to alleviate vaginal dryness.
• women taking medication for urinary incontinence
• women not sexually active, for other reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vaginal DHEA	Vaginal DHEA	Vaginal DHEA 0.5%(6.5mg)inserted nightly

Primary Outcome Measures

Name	Time	Method
improvement in vaginal dryness	12 weeks

Secondary Outcome Measures

Name	Time	Method
improvement in urinary incontinence	12 weeks
improvement in sexual satisfaction	12 weeks

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel