NCT01724242

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 28, 2017

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

November 7, 2012

Last Update Submit

November 26, 2017

Conditions

Vaginal DrynessBreast CancerUrinary IncontinenceQuality of LifeSexual Satisfaction

Keywords

Vaginal drynessBreast CancerUrinary IncontinenceQuality of LifeSexual Satisfaction

Outcome Measures

Primary Outcomes (1)

  • improvement in vaginal dryness

    12 weeks

Secondary Outcomes (2)

  • improvement in urinary incontinence

    12 weeks

  • improvement in sexual satisfaction

    12 weeks

Study Arms (2)

Vaginal DHEA

EXPERIMENTAL

Vaginal DHEA 0.5%(6.5mg)inserted nightly

Drug: Vaginal DHEA

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Vaginal DHEADRUG
Vaginal DHEA
PlaceboDRUG
Placebo

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • women using products to alleviate vaginal dryness.
  • women taking medication for urinary incontinence
  • women not sexually active, for other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Breast NeoplasmsUrinary IncontinenceOrgasm

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Study Officials

  • Drorith Hochner-Celnikier, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 9, 2012

Study Start

February 1, 2013

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

November 28, 2017

Record last verified: 2015-07

Locations

IL(1)