Vaginal DHEA for Women After Breast Cancer

Hadassah Medical Center

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Breast Cancer; Quality of Life; Vaginal Dryness; Urinary Incontinence; Sexual Satisfaction

Treatments: Drug: Vaginal DHEA; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01724242

DHEA-HMO-CTIL

Details and patient eligibility

About

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.

Sex: Female

Ages: 35 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Vaginal DHEA

Experimental group

Description:

Vaginal DHEA 0.5%(6.5mg)inserted nightly

Treatment:

Drug: Vaginal DHEA

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo