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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal estradiol 10 μg | Active Comparator |
| |
| Vaginal DHEA 6,5 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal estradiol 10 μg | Drug | Vagifem® (estradiol), vaginal tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspareunia, a symptom of VVA in postmenopausal women | Patient reports in the Vaginal Atrophy Symptoms Questionnaire (VASQ, section 1). A 4-point scale, where a higher point means more symptoms. | Primary endpoint will be evaluated as change in dyspareunia (VASQ section 1) from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Total symptom score of VVA | Vaginal dryness and irritation/itching (VASQ, section 2 and 3, a 4-point scale, where a higher point means more symptoms) | Change from baseline to Week 4 and 12 |
| Clinical signs of VVA |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual activity | Sexual activity log (SAL, the number of satisfying sexual episodes over a 1-week period) | Change from baseline to Week 4 and 12 |
| Sexual distress | the Personal Distress Scale (PDS, 0 [no distress] to 100 [maximum distress]). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 171 76 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903372 | Derived | Strandberg M, Cockin A, Hirschberg AL. Effects of vaginal dehydroepiandrosterone and estradiol on dyspareunia, a symptom of vulvovaginal atrophy in postmenopausal women - a randomized controlled trial. Maturitas. 2026 May;208:108924. doi: 10.1016/j.maturitas.2026.108924. Epub 2026 Mar 20. |
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| vaginal DHEA 6.5 mg |
| Drug |
Intrarosa® (dehydroepiandrosterone; DHEA; prasterone), pessaries |
|
Examination of vaginal atrophy symptoms (VAX). A 4-point scale, where a higher point means more symptoms.
| Change from baseline to Week 4 and 12 |
| Sexual function | Profile of Female Sexual Function (PFSF) and its seven domains desire, arousal, orgasm, pleasure, concern, responsiveness and self-image (range from 0 to 100, where a lower score means more dysfunction) | Change from baseline to Week 4 and 12 |
| Urinary incontinence | The Incontinence Impact Questionnaire (IIQ-7, a 4-point scale, where a higher point means more symptoms) | Change from baseline to Week 4 and 12 |
| Histomorphology of the vaginal wall | Histomorphology (thickness of epithelium, lamina propria and muscle layer in vaginal biopsies) | Change from baseline to Week 4 and 12 |
| Sex hormone levels | Sex hormone levels (estradiol and testosterone) | Change from baseline to Week 4 and 12 |
| Change from baseline to Week 4 and 12 |
| Urogenital distress | Urogenital Distress Inventory (UDI-6, a 4-point scale, where a higher point means more symptoms) | Change from baseline to Week 4 and 12 |