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Vaginal DHEA for Women After Breast Cancer

NCT ID: NCT01724242

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaginal Dryness Breast Cancer Urinary Incontinence Quality of Life Sexual Satisfaction

Keywords

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Vaginal dryness Breast Cancer Urinary Incontinence Quality of Life Sexual Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vaginal DHEA

Vaginal DHEA 0.5%(6.5mg)inserted nightly

Group Type EXPERIMENTAL

Vaginal DHEA

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vaginal DHEA

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Drorith Hochner-Celnikier, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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DHEA-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id