Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause

Completed · Not applicable

Conditions studied: Vaginal Atrophy, Sexual Dysfunction, Dyspareunia, Vaginal Dryness, Chronic UTI

In brief

This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of Menopause.

Key facts

Study ID

NCT03178825

Run by

Sciton

People needed

60

Starts

2017-05-19

Expected to finish

2020-02-25

Last updated by the study team

2020-08-11

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Healthy biological female aged between 40 to 70 years
• 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
• Is experiencing at least two self-reported symptoms of GSM, such as
• Vaginal irritation in 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)
• Has been experiencing symptoms of GSM for greater than 3 months
• Is unable due to medical contraindication or unwilling to receive hormone-based vaginal therapy
• Normal and up-to-date pap smear if applicable
• Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve
• Can read, understand and sign informed consent form

You may not qualify if…

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

Where it is running

• Women's Pelvic Health Institute — Los Gatos, California, United States
• Coyle Institute — Pensacola, Florida, United States
• Louisiana State University — New Orleans, Louisiana, United States
• Carolinas Healthcare System — Charlotte, North Carolina, United States
• Woodlands Gynecology & Aesthetics — The Woodlands, Texas, United States
• The Female Pelvic Medicine Institute of Virginia — North Chesterfield, Virginia, United States

Full record on ClinicalTrials.gov

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