Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms

Inclusion Criteria

• Age ≥ 18 years
• Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease). Note: Postmenopausal status will be determined by the following criteria:
• 12 months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study
• menopausal status will be determined by an FSH and an estradiol value in the postmenopausal range (generally FSH > 40IU/L and estradiol 12 months.
• Ability to complete questionnaires by themselves or with assistance.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
• The patient must provide informed written consent.
• Willing to return to the enrolling institution for follow-up.
• Willing to provide blood samples for correlative research purposes.

Exclusion Criteria

• Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 12-week study.
• Current diagnosis of an active vaginal infection, if symptoms of vaginal infection, this must be ruled out (ie, foul discharge, fever).
• Concurrent chemotherapy (long term adjuvant herceptin, lapatanib, and/or bevacizumab is allowed.
• Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Water-based lubricants (such as KY jelly) are allowed during sexual intercourse.
• Use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry.

Exception: Daily water-based lubricants for sexual intercourse. Note: Patients who stop agent may be enrolled after one week.

• Current (≤ 4 weeks prior to randomization), or planned during the study period, use of any estrogen product or any kind of hormonal vaginal product including bioidentical hormones, estriol or any androgen product.
• Use of pharmacologic soy or phytoestrogen preparations (Dietary intake of soy - ie milk is acceptable).
• On a placebo controlled trial for endocrine therapy.
• Prior or concurrent pelvic radiation therapy.
• Prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration (TAH/BSO) is allowed).
• Diagnosis of any of the following conditions within the past five years:
• Essential vulvodynia
• Vulvar vestibulitis
• Bartholin cyst/abscess
• History of Bartholin gland surgery
• Lichen sclerosis
• Lichen planus of the vulvovaginal region
• Desquamative vaginitis
• History or current diagnosis of any of the following conditions:
• Vulvar or vaginal dysplasia
• Vaginal prolapse
• Women of childbearing potential, premenopausal women.