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NCT06007027
Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors
NA trial testing SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy in Genitourinary Syndrome of Menopause in 60 participants. Currently enrolling.
30 January 2026
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 December 2024 |
| Primary completion | 30 January 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
Conditions studied
- Genitourinary Syndrome of Menopause — all drugs for Genitourinary Syndrome of Menopause →
Sponsor
University of Aarhus
Who can join
Adults 18 to 100, female only, with Genitourinary Syndrome of Menopause. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Vaginal CO<sub>2</sub> laser therapy for genitourinary syndrome in breast cancer survivors-VagLaser study protocol: a randomized blinded, placebo-controlled trial.
Jacobsen S, Glavind-Kristensen M, Jensen AB, Forman A, et al · · 2023 · cited 3× · PMID 38031020 · DOI 10.1186/s12885-023-11656-x -
Impact of fractional CO<sub>2</sub> laser therapy on vaginal wall histology in breast cancer survivors.
Jacobsen S, Bennetsen MH, Nielsen PS, Glavind-Kristensen M, et al · · 2026 · PMID 41665827 · DOI 10.1007/s10103-026-04829-0
Verify or expand the search:
- PubMed search for NCT06007027
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Genitourinary Syndrome of Menopause
Currently open trials in the same condition.
- NCT06873971 — Er:YAG Laser Combined With Vaginal Estriol for Genitourinary Syndrome of Menopause · NA · recruiting
- NCT06508788 — Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndro · recruiting
- NCT06925139 — Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women · NA · active not recruiting
- NCT06028009 — PRP Injections for Genitourinary Syndrome of Menopause · NA · active not recruiting
- NCT06124820 — RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women with Recurrent Urinary Tract Infections · NA · active not recruiting
Other University of Aarhus trials
Trials by the same sponsor.
- NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
- NCT07317401 — Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Post-Viral Myalgic Encephalo · NA · not yet recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
- NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
- NCT07451028 — Effect of an Oral Neuromuscular Training Device on Dysphagia · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06007027 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 5 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06007027.
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