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OpenTrials
Completed

NCT Number: NCT03647189

Randomized, Controlled Trial With Hybrid Fractional Laser

This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Healthy biological female aged between 40 to 70 years 2. Is post-menopausal with a AND b OR c:
  • No menses for at least 12 months
  • Follicle-stimulating hormone (FSH) level over 40mlU/mL
  • Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement 3. Is experiencing at least two self-reported symptoms of GSM, such as

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  • Vaginal irritation in the absence of infection
  • Chronic burning sensation
  • Chronic itching in the absence of infection
  • Recurring urinary tract infections (UTIs)
  • Vaginal dryness during sexual activity
  • Pain during sexual activity (dyspareunia) 4. Has been experiencing symptoms of GSM for greater than 3 months 5. Is unable due to a medical contraindication or unwilling to receive hormone-based vaginal therapy 6. Early menopause after breast cancer 7. Normal and up to date pap smear, if applicable 8. Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve 9. Can read, understand and sign informed consent form 10. Has indicated willingness to participate in the study by signing an informed consent form 11. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion criteria

  • 1. Undiagnosed abnormal genital bleeding 2. Has history of pelvic surgery or other energy-based vaginal therapy within 12 months prior to enrollment 3. Previous use of topical estrogen therapy within the last 6 months 4. Has used vaginal creams, moisturizers, lubricants or homeopathic preparations, or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment 5. Has history of heart failure 6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q) 7. Has an active sexually transmitted infection (STI) 8. Has signs or symptoms of vulvitis/vaginitis 9. Has signs or symptoms of acute urinary tract infection (UTI) 10. Has participated in any clinical trial involving an investigational drug or procedure within past 30 days 11. The investigator feels that for any reason the subject is not eligible to participate in the study

Treatment and study plan

Hybrid fractional laser

Device

Hybrid Fractional Laser

Primary outcomes

  1. Change from baseline in Vaginal health index score (VHIS)

    Time frame: 6 months

    Scores vaginal health by scoring it from 1(none) - 5(excellent).

  2. Change from baseline in Female sexual function index questionnaire (FSFI)

    Time frame: 6 months

    Scoring 0(minimum) - 5(maximum)

  3. Change from baseline in day-to-day impact of vaginal aging questionnaire

    Time frame: 6 months

    Questionnaire

  4. Change from baseline in histology

    Time frame: 3 months

    Histology

Secondary outcomes

  1. Change from baseline in photography

    Time frame: 6 months

    Photography

Sponsors and collaborators

Lead sponsor

Sciton

Industry

Registry information

Official study title

Randomized, Controlled Trial With Hybrid Fractional Laser for Vulvovaginal Atrophy in Breast Cancer Survivors and Menopausal Females

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2018
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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