Population and design

These data were collected as part of a phase III randomized controlled trial evaluating two doses (3.25 mg/d and 6.5 mg/d) of vaginal DHEA compared to a plain moisturizer (PM). Eligibility criteria included women who reported problems with either vaginal dryness or dyspareunia, were postmenopausal, had a history of breast or gynecologic cancer, completed curative intent treatment and had no evidence of disease. Participants could be on endocrine therapy (tamoxifen or aromatase inhibitors) but had to be on it for the past two months without planned changes. Women could not be using vaginal products other than water-based lubricants during intercourse, nor could they be using any oral or transdermal hormonal products (i.e., estrogen), including soy or compounded hormones. They could not have had prior or current radiation therapy to the pelvis nor have had any active vaginal infections. All women were asked to provide a blood sample at baseline and at 12 weeks. Additionally, a small subset of accruing sites volunteered to participate in vaginal cytology collection and vaginal pH measurement.