Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

NCT02747641

Atrophy Vaginal Atrophy Genital Diseases, Female

COMPLETED NA

Clitoral Sensitivity Enhancement With Laser

NCT07152704

Decreased Clitoral Sensitivity

COMPLETED NA

Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus

NCT03063684

Vaginal Atrophy Lichen Sclerosus

COMPLETED NA

Efficacy and Safety of CO₂ Laser Therapy Combined With Collagen Cream in Managing Vulvo-Vaginal Atrophy: A Randomized, Controlled Study on Symptom Relief and Microbiome Modulation

NCT07246616

Vulva; Atrophy

COMPLETED NA

The Use of Laser in the Treatment of Atrophic Vulvovaginitis

NCT04297319

Lasers Atrophy of Vagina Atrophy Vulva

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vulvovaginal Atrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laser Treatment

Group Type EXPERIMENTAL

Laser treatment

Intervention Type DEVICE

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laser treatment

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
* Exhibiting VVA symptoms
* Prolapse staged \< II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
* Have not had procedures in the anatomical area through 6 months prior to treatment
* Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria

* • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).

* Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
* Any serious disease, or chronic condition, that could interfere with the study compliance
* Previously undergone reconstructive pelvic surgery
* Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
* Taking medications that are photosensitive
* A history of keloid formation

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes