Laser therapy for vaginal symptoms in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project involves three studies over three years focusing on breast cancer survivors experiencing genitourinary syndrome. The first study assesses the dose response of laser treatments in 30 participants, followed by a double-blind randomized controlled trial with 60 participants to compare active laser treatment against a placebo. The final study includes a one-year follow-up to evaluate the long-term effects of the treatment. Assessments will include questionnaires, vaginal fluid pH, biopsies, and microbiome analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Breast cancer survivor in endocrine therapy
* Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
* Able to read and understand Danish
* Able to give written informed consent

Exclusion Criteria:

* Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
* Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
* Use of Chemotherapy (6 months prior to the baseline visit)
* Acute urinary tract infection or active genital infection
* History of vaginal reconstructive surgery

Where it's running

• Department of Obstetrics and Gynaecology, Randers Regional Hospital
  Randers, Denmark Recruiting

Study contacts

• Study coordinator: Sine Jacobsen, MD
• Email: sinjac@rm.dk
• Phone: +4578421069

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Burden of vaginal and urinary menopause symptoms in breast cancer survivors

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• Nonhormonal vulvovaginal gel to relieve menopausal vulvovaginal symptoms

  This will test a hormone-free vulvovaginal gel in postmenopausal women with genitourinary syndrome of menopause to see if it reduces vaginal atrophy symptoms and improves daily quality of life.

  Recruiting Mucosa Innovations, S.L. · Madrid, Madrid · NCT06962345

• Combining topical hyaluronic acid with high-concentration oxygen therapy for menopausal symptoms

  This study is testing if a treatment that combines a special gel and high-concentration oxygen can help postmenopausal women, including those who had breast cancer, feel better by reducing vaginal dryness and other symptoms.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT06879938

• Er:YAG laser plus vaginal estriol for menopausal genitourinary symptoms

  This trial will test whether adding Er:YAG laser treatment to low‑dose vaginal estriol helps postmenopausal women with genitourinary syndrome of menopause.

  Recruiting University of Nove de Julho · São Paulo, São Paulo · NCT06873971

• Telerehabilitation program for improving sexual function and reducing pain in menopausal women

  This study is testing a telerehabilitation program to see if it can help menopausal women with painful sex feel better and improve their overall quality of life compared to regular in-person therapy.

  Recruiting Instituto Médico Tecnológico SL · Barcelona, Spain · NCT06710002

• Vaginal treatment for menopause symptoms using CO2 laser

  This study is testing if a CO2 laser treatment can help relieve vaginal dryness and discomfort in women going through menopause who can't use hormone therapy.

  Recruiting University of California, Irvine · Irvine, California · NCT06691178

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.