Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Vulvovaginal atrophy (VVA) is a condition characterized by vaginal dryness, itching, burning,
irritation and dyspareunia. The condition is mainly due to estrogen deficiency and is common
during and after menopause. Furthermore, androgens may have an important function in these
symptoms. The purpose of the study is to compare vaginal estrogen with vaginal
dehydroepiandrosterone (DHEA, an androgen precursor) on dyspareunia (primary outcome), a
symptom of VVA in postmenopausal women. Secondary outcomes are total symptom score of VVA
(vaginal dryness, irritation/itching, maturation index, pH), clinical signs of VVA, sexual
function, urogenital symptoms, vaginal histomorphology, sex hormone levels and short-term
safety. The hypothesis of the study is that the treatments will have a similar effect on
dyspareunia while DHEA, through local androgenic effects (eg growth of muscle tissue and
nerve density in the vaginal wall), may be more effective in treating other related symptoms
such as sexual dysfunction. 170 postmenopausal women will be randomly assigned to treatment
with either vaginal estrogen (Vagifem) or vaginal DHEA (Intrarosa). The women are examined at
the start of the study, after 4 weeks of daily application and after another 8 weeks of
treatment with twice a week application of the vaginal treatment. The study is expected to
provide increased knowledge about the effect of the treatments of VVA in postmenopausal women
as well as whether vaginal DHEA has additional positive effects on sexual function compared
to vaginal estrogen.