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Vaginal DHEA for Women After Breast Cancer

This study has been withdrawn prior to enrollment.
(Inability to recruit patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724242
First Posted: November 9, 2012
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hadassah Medical Organization
  Purpose
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
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

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 ]

Secondary Outcome Measures:
  • improvement in urinary incontinence [ Time Frame: 12 weeks ]
  • improvement in sexual satisfaction [ Time Frame: 12 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724242


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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01724242     History of Changes
Other Study ID Numbers: DHEA-HMO-CTIL
First Submitted: November 7, 2012
First Posted: November 9, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015

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
Enuresis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs