Vaginal DHEA for Women After Breast Cancer

This study has been withdrawn prior to enrollment.
(Inability to recruit patients)
Information provided by (Responsible Party):
Hadassah Medical Organization Identifier:
First received: November 7, 2012
Last updated: July 26, 2015
Last verified: July 2015
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 Intervention Phase
Vaginal Dryness
Breast Cancer
Urinary Incontinence
Quality of Life
Sexual Satisfaction
Drug: Vaginal DHEA
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • improvement in vaginal dryness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement in urinary incontinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • improvement in sexual satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal DHEA
Vaginal DHEA 0.5%(6.5mg)inserted nightly
Drug: Vaginal DHEA
Placebo Comparator: Placebo


Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01724242

Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Drorith Hochner-Celnikier, MD Hadassah Medical Organization
  More Information

Responsible Party: Hadassah Medical Organization Identifier: NCT01724242     History of Changes
Other Study ID Numbers: DHEA-HMO-CTIL 
Study First Received: November 7, 2012
Last Updated: July 26, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Vaginal dryness
Breast Cancer
Urinary Incontinence
Quality of Life
Sexual Satisfaction

Additional relevant MeSH terms:
Breast Neoplasms
Urinary Incontinence
Breast Diseases
Lower Urinary Tract Symptoms
Neoplasms by Site
Signs and Symptoms
Skin Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations processed this record on May 24, 2016