Fernand Labrie MD, PhD; Leonard Derogatis PhD; David F. Archer MD; William Koltun MD; Andrée Vachon MD; Douglas Young MD; Louise Frenette MD; David Portman MD; Marlene Montesino MD; Isabelle Côté BSc; Julie Parent PhD; Lyne Lavoie MSc; Adam Beauregard BSc, MBA; Céline Martel PhD; Mario Vaillancourt BSc, MBA; John Balser PhD; Érick Moyneur BSc, MA; and Members of the VVA Prasterone Research Group
ONLINE: November 23, 2015 – The Journal of Sexual Medicine
As women age, their levels of serum dehydroepiandrosterone (DHEA) decreases, with an average loss of 60% at menopause. Because of estrogen declines at menopause, DHEA becomes the only source of sex steroids.
Sexual dysfunction is common among postmenopausal women. However, past studies have shown sexual improvements in women who receive local DHEA. Symptoms of vaginal atrophy also improved for these women.
Past research using the menopause-specific quality of life (MENQUOL) and abbreviated sexual function (ASF) questionnaires showed that intravaginal prasterone could improve different domains of female sexual function.
Stemming from this research, the present study was a placebo-controlled, randomized, double-blind prospective clinical trial. The primary objective was to confirm the efficacy of daily intravaginal administration of 0.50% DHEA ovules (suppositories) for 12 weeks on moderate to severe pain at sexual activity using the Female Sexual Function Index (FSFI). The secondary objective was to evaluate the benefits on sexual function.
Participants were randomized in a 2:1 ratio to receive 0.50% DHEA (prasterone) or placebo. All of the women were postmenopausal with vulvovaginal atrophy (VVA), moderate to severe dyspareunia, ≤5% of vaginal superficial cells, and vaginal pH > 5.0. None of the women had fibroids and endometrial polyps.
Several types of medications and products were not allowed during the study period, including hormone replacement therapy, progestogen medication, natural oral “estrogenic” products, vaginal creams or gels, vaginal lubricants, and vaginal douches.
Participants were instructed to insert one intravaginal ovule (suppository) each day before bedtime for twelve weeks. Each woman filled out a daily diary card to record the time of her dose.
Main Outcome Measure
The 19-item FSFI questionnaire was administered at the screening visit, day 1, week 6, and week 12 (or at discontinuation if the participant completed six weeks). This tool assesses six sexual function domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) during the previous four weeks.
Participants ranged in age from 40–80 years with a mean age of 59.5 years. All were postmenopausal. On average, 13.9 years had passed between their last menses and participation in the study.
The final analysis was based on 325 women for the DHEA group and 157 women for the placebo group.
Overall, the DHEA group had higher scores on all six FSFI domains when compared to the placebo group, indicating improved sexual function. Total FSFI scores were also higher in the DHEA group.
Past research has shown that DHEA applied directly to the vagina does not significantly change serum levels of testosterone or other steroids, which remain within normal postmenopausal values.
“Such data indicate that DHEA, by a strictly local action, exerts important beneficial effects on sexual function in women without systemic action on the brain and other extravaginal tissues,” the authors wrote.
They added that it “seems possible that increased favorable outputs from a healthier vaginal mucosa could influence the brain to express increased desire/interest without the need for a direction action of hormones on the brain.”