Vaginal DHEA for Women After Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01724242
• Other study ID #: DHEA-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 7, 2012
• Last updated: November 26, 2017
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Enuresis
• Quality of Life
• Sexual Satisfaction
• Urinary Incontinence
• Vaginal Dryness

Intervention

Drug:
• Vaginal DHEA

• Placebo

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in vaginal dryness		12 weeks
Secondary	improvement in urinary incontinence		12 weeks
Secondary	improvement in sexual satisfaction		12 weeks