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Vaginal DHEA for Women After Breast Cancer

Primary Purpose

Vaginal Dryness, Breast Cancer, Urinary Incontinence

Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Vaginal DHEA
Placebo
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Dryness focused on measuring Vaginal dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaginal DHEA

Placebo

Arm Description

Vaginal DHEA 0.5%(6.5mg)inserted nightly

Outcomes

Primary Outcome Measures

improvement in vaginal dryness

Secondary Outcome Measures

improvement in urinary incontinence
improvement in sexual satisfaction

Full Information

First Posted
November 7, 2012
Last Updated
November 26, 2017
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01724242
Brief Title
Vaginal DHEA for Women After Breast Cancer
Official Title
Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to recruit patients
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction
Keywords
Vaginal dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal DHEA
Arm Type
Experimental
Arm Description
Vaginal DHEA 0.5%(6.5mg)inserted nightly
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vaginal DHEA
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
improvement in vaginal dryness
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
improvement in urinary incontinence
Time Frame
12 weeks
Title
improvement in sexual satisfaction
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drorith Hochner-Celnikier, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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Vaginal DHEA for Women After Breast Cancer

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