NCT05586711

Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

Completed Phase 4 Last updated 17 December 2024

What this trial tests

Phase 4 trial testing vaginal estradiol 10 μg in Vulvovaginal Atrophy in 170 participants. Completed in 15 December 2024.

Timeline

18 December 2020

Primary endpoint
15 December 2024

15 December 2024

Quick facts

Lead sponsor	Angelica Lindén Hirschberg
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	170
Start date	18 December 2020
Primary completion	15 December 2024
Estimated completion	15 December 2024
Sites	1 location across Sweden

Drugs / interventions tested

• vaginal estradiol 10 μg — full drug profile →
• vaginal DHEA 6.5 mg — full drug profile →

Conditions studied

• Vulvovaginal Atrophy — all drugs for Vulvovaginal Atrophy →
• Genitourinary Syndrome of Menopause — all drugs for Genitourinary Syndrome of Menopause →

Sponsor

Angelica Lindén Hirschberg — full company profile →

Who can join

Adults 40 to 80, female only, with Vulvovaginal Atrophy or Genitourinary Syndrome of Menopause. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hormone replacement therapy in gynecological cancer survivors and BRCA mutation carriers: a MITO group survey.
   Palaia I, Caruso G, Di Donato V, Turetta C, et al · · 2024 · cited 6× · PMID 38497108 · DOI 10.3802/jgo.2024.35.e70
2. Effects of vaginal dehydroepiandrosterone and estradiol on dyspareunia, a symptom of vulvovaginal atrophy in postmenopausal women - a randomized controlled trial.
   Strandberg M, Cockin A, Hirschberg AL. · · 2026 · PMID 41903372 · DOI 10.1016/j.maturitas.2026.108924