[Lisalou]

Found it. It was an abstract from the ASCO proceedings. Turns out I know the researcher. Still off label use.

IMPACT OF VAGINAL DEHYDROEPIANDOSTERONE (DHEA) ON VAGINAL SYMPTOMS IN CANCER SURVIVORS TRIAL N10C1 (Alliance)

Debra L. Barton1, Jeff A. Sloan2, Lynn T. Shuster1, Travis Dockter1, Paula Gill1, James D. Bearden3, Pamela J Atherton1 , David B. Johnson4, Philip J. Stella5, Shelby Terstreip6, Fauzia N. Rana7, David M. Anderson8 and Charles L. Loprinzi1

1Mayo Clinic, Rochester, MN
2 Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN
3Upstate Carolina CCOP, Spartanburg, SC
4Wichita CCOP, Wichita, KS
5Michigan Cancer Research Consortium, Ann Arbor, MI
6Sanford Community Cancer Consortium CCOP, Fargo, ND
7University of Florida, Jacksonville, FL
8Metro-MN CCOP, St. Louis Park, MN
Introduction: Impaired sexual satisfaction is a prevalent and distressing issue for female cancer survivors. The aim of this study was to evaluate the impact of vaginal DHEA on vaginal atrophy symptoms and sexual function.

Methods: A controlled, randomized trial evaluating 3.25 versus 6.5 mg of DHEA vaginally was conducted. Postmenopausal women with previous breast or gynecologic cancer were eligible if they reported ≥ moderate vaginal dryness or dyspareunia. DHEA was compounded in a bioadhesive vaginal moisturizer. Women inserted the bioadhesive moisturizer with or without DHEA using a pre-filled syringe daily x 12 weeks before going to sleep, after any sexual activity. The most bothersome vaginal symptom (dryness or pain) was evaluated with a single item Likert scale, and sexual function with the Female Sexual Function Index (FSFI). Side effects were graded by providers using the Common Terminology Criteria for Adverse Events (CTCAE) and self-report. Laboratory tests to assess systemic absorption were done. Analysis of change from baseline to 12 weeks (primary endpoint) included independent t-tests, comparing each DHEA treatment arm with plain moisturizer.

Results: 441 women from 82 institutions were randomized, 147 in each arm. Women in all 3 arms reported significant improvement in their most bothersome symptom. Cohen’s d effect size for severity decrease was 1.4, 1.6 for DHEA 3.25, 6.5 mg respectively and 1.3 without DHEA. Compared with no DHEA, women receiving DHEA 6.5 mg reported statistically significant improvements in sexual function at 12 weeks, based on the FSFI full scale score as well as all sexual domain scores except orgasm (p-values <.0001 to 0.03.). Effect sizes ranged from 0.3 to 0.6. There were no significant differences in grade 2/3 toxicities. Two self-reported side effects, voice changes and headaches, were worse for DHEA arms compared to no DHEA. Lab data demonstrated no evidence of clinically important systemic estrogenic activity.

Conclusions: These data support the use of a daily vaginal moisturizer to improve vaginal atrophy symptoms. Vaginal DHEA significantly improves sexual desire, arousal, pain and overall sexual function, compared to this bioadhesive moisturizer alone.