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Vaginal DHEA for Women After Breast Cancer

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ClinicalTrials.gov Identifier: NCT01724242
Recruitment Status : Withdrawn (Inability to recruit patients)
First Posted : November 9, 2012
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
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 : February 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. improvement in vaginal dryness [ Time Frame: 12 weeks ]

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


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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.

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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01724242     History of Changes
Other Study ID Numbers: DHEA-HMO-CTIL
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: November 28, 2017
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