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WithdrawnNCT01724242Updated Nov 28, 2017

Vaginal DHEA for Women After Breast Cancer

A Phase 2/3 interventional study of Vaginal DHEA and Placebo in Vaginal Dryness, Breast Cancer and Urinary Incontinence, sponsored by Hadassah Medical Organization. Withdrawn at 1 site in Israel. Open to female participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Hadassah Medical Organization · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
Inability to recruit patients
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
35 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Vaginal Dryness
  • Breast Cancer
  • Urinary Incontinence
  • Quality of Life
  • Sexual Satisfaction

Keywords

  • Vaginal dryness
  • Breast Cancer
  • Urinary Incontinence
  • Quality of Life
  • Sexual Satisfaction
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • women using products to alleviate vaginal dryness.
  • women taking medication for urinary incontinence
  • women not sexually active, for other reasons.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Vaginal DHEA

    Vaginal DHEA 0.5%(6.5mg)inserted nightly

    Drug: Vaginal DHEA

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugVaginal DHEA
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. improvement in vaginal dryness

    Time frame: 12 weeks

Secondary outcomes

  1. improvement in urinary incontinence

    Time frame: 12 weeks

  2. improvement in sexual satisfaction

    Time frame: 12 weeks

07

Study locations

1 site
  • Hadassah Medical Organization
    Jerusalem, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01724242
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Nov 9, 2012
Start date
Feb 2013
Primary completion
Jan 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Nov 28, 2017

Study contacts

Drorith Hochner-Celnikier, MD
principal investigator · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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