Vaginal DHEA for Women After Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01724242
First received: November 7, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  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
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 ]

Estimated Enrollment: 60
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

Ages Eligible for Study:   35 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724242

Contacts
Contact: Drorith Hochner-Celnikier, MD 00 972 2 5844400 hochner@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Drorith Hochner-Celnikier, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Drorith Hochner-Celnikier, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01724242     History of Changes
Other Study ID Numbers: DHEA-HMO-CTIL
Study First Received: November 7, 2012
Last Updated: November 7, 2012
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
Neoplasms by Site
Neoplasms
Urinary Incontinence
Breast Diseases
Skin Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014