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Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy


Phase 2/Phase 3
35 Years
55 Years
Not Enrolling
Female
Vaginal Dryness, Breast Cancer, Urinary Incontinence, Quality of Life, Sexual Satisfaction

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Trial Information

Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

improvement in vaginal dryness

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Drorith Hochner-Celnikier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Ministry of Health

Study ID:

DHEA-HMO-CTIL

NCT ID:

NCT01724242

Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

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

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