Objectives: The primary objective was to evaluate the efficacy of vaginal dehydroepiandrosterone (DHEA) and estradiol (E2) on dyspareunia, a symptom of vulvovaginal atrophy (VVA) in postmenopausal women.
Study design: In an open-label, randomized controlled trial, 172 naturally postmenopausal women with a mean age of 62.4 ± 5.7 years and moderate or severe dyspareunia caused by VVA, received DHEA (6.5 mg pessaries) or E2 (10 μg vaginal tablets) daily for 4 weeks and then twice-weekly up to 12 weeks. Symptoms and signs of VVA were assessed at baseline, week 4 and 12 of treatment.
Main outcome measures: The primary outcome was the proportion of patients in each treatment group achieving an improvement of 1 point or more in dyspareunia score on a 4-point scale (none, mild, moderate, severe). Secondary outcomes included other symptoms and objective signs of VVA.
Results: Women in both groups had improved in dyspareunia by week 12 (DHEA 92% and E2 82%), with a tendency of significant difference between the groups (OR 2.87, 95% CI 1.00-8.25; p = 0.051). For those with severe dyspareunia at baseline there was higher odds of improvement in the DHEA group than in the E2 group (OR 3.4, 95% CI 1.07-10.5). Vaginal pH, maturity index, and total score for clinical signs of atrophy improved more in the E2 group than in the DHEA group.
Conclusion: Vaginal DHEA tended to improve dyspareunia more than E2 and was superior in alleviating severe dyspareunia in postmenopausal women. On the other hand, vaginal E2 was superior in improving clinical subjective and objective signs of VVA.
Clinicaltrial: gov registration number NCT05586711.