Clinical trial · Interventional
Laser vs Hyaluronic Acid for GSM in Breast Cancer
Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
All women from the outpatient department with a history of BC and GSM (genitourinary symptoms of menopause) symptoms will be invited to participate. After informed consent patients are either randomized to intravaginal laser or hyaluronic acid suppository treatment intravaginally, respectively. Laser treatment will be performed twice, at baseline and after 1 month. The intravaginal hyaluronic acid suppository therapy will be applied daily during the first 10 days and then every third day until the three months follow-up. At baseline and three months follow-up the following questionnaires will be filled out (VAS, (PGI-I, PGI-S, Female Sexual health questionnaire (EORTC), Baessler questionnaire, EORTC quality of life questionnaire, ZUF-8).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urogenital Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cikatridina | Device | — | UNRESOLVED |
| Juliet Feminine Laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- hyaluronic acid suppository therapy
- description
- Women receive a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria. The suppositories contain ontain hyaluronic acid, tea tree oil, tigergras extract, and aloe vera.
- interventionNames
- Device: Cikatridina
- type
- ACTIVE_COMPARATOR
- label
- Juliet feminine laser
- description
- The fractional microablative laser with 2940 nm wavelength has a high degree of absorption in water and selectively stimulates the synthesis of sub-mucosal collagen. The erbium-doped yttrium-aluminum-garnet (Er:YAG) laser has been successfully used in the field of plastic skin rejuvenation and reconstruction. The procedure is based on photothermic treatment of connective tissue: It has been established in animal and human studies that it affects collagen remodeling resulting in tightening of the supportive tissue.
- interventionNames
- Device: Juliet Feminine Laser
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria * genital symptoms of dryness/ burning/ irritation * and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain * and/or symptoms of urgency and dysuria or recurrent urinary tract infection * Age 18-80 * History of BC and/ or DCIS * Completed locoregional therapy * Current antihormonal therapy for BC possible * Intravaginal treatment with creams/ suppositories other than study medicationshould be ceased during the trial Exclusion criteria: * Current or past genitourinary malignancy * Abnormal PAP smear * Current genitourinary tract infection * Abnormal uterine bleeding * photosensitive medication
References
Publications (2)
- DERIVEDGold D, Nicolay L, Avian A, Greimel E, Balic M, Pristauz-Telsnigg G, Tamussino K, Trutnovsky G. Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial. Maturitas. 2023 Jan;167:1-7. doi: 10.1016/j.maturitas.2022.08.013. Epub 2022 Sep 9. PMID 36279690
- DERIVEDEuropean Urogynaecological Association 2021 Annual Meeting | Hybrid Edition. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):244-271. doi: 10.1097/SPV.0000000000001172. No abstract available. PMID 35443258