Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Postmenopausal women with a history of breast or gynecologic cancer (currently no
evidence of disease)

- Postmenopausal status 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

- FSH and an estradiol value in the postmenopausal range (generally FSH >40
IU/L and estradiol < 10 pg/mL, depending on laboratory) if 9 months without
a period OR post hysterectomy with at least one ovary remaining and less
than 55 years old

- For age 55 or older, menopausal status does not need to be determined by
laboratory exams

- Significant vaginal complaints defined as persistent vaginal dryness and/or pain with
intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic
intervention

- Eligibility questionnaire response must be moderate or worse levels of severity on
one of the two symptoms, either dryness or dyspareunia

- Vaginal symptoms must have been present ≥ 2 months prior to randomization

PATIENT CHARACTERISTICS:

- Life expectancy > 12 months

- ECOG performance status 0 or 1

- Ability to complete questionnaires by themselves or with assistance

- Willing to return to NCCTG enrolling institution for follow-up

- Willing to provide blood samples for correlative research purposes

- Willing to undergo brief pelvic exam at baseline and week 11-12, if institution
participating in that portion of the study

- No current diagnosis of an active vaginal infection; if symptoms of vaginal infection
(i.e., foul discharge, fever) present, then infection must be ruled out

- No 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

- No history or current diagnosis of any of the following conditions (ever):

- Vulvar or vaginal dysplasia

- Vaginal prolapse

- No women of childbearing potential or premenopausal women

PRIOR CONCURRENT THERAPY:

- No initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months
prior to randomization or plan to initiate or discontinue any of these medications
during the 12-week study

- No concurrent chemotherapy

- Long-term adjuvant trastuzumab, lapatinib, and/or bevacizumab is allowed

- Not planning to use any vaginal preparations during the study period (including any
over-the-counter or herbal preparations)

- Water-based lubricants, such as KY jelly, are allowed during sexual intercourse

- No use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry

- Patients who stop agent may be enrolled after 1 week

- More then 4 weeks since prior and no concurrent use of any estrogen product or any
kind of hormonal vaginal product including bio-identical hormones, estriol, or any
androgen product

- No concurrent pharmacologic soy or phytoestrogen preparations (dietary intake of soy
[i.e., soy milk] is acceptable)

- Not on a placebo-controlled trial for endocrine therapy

- No prior or concurrent pelvic radiotherapy

- No prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration

- Prior total abdominal hysterectomy (TAH) and/or bilateral salpingo-oophorectomy
(BSO) allowed