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Completed

NCT Number: NCT07152704

Clitoral Sensitivity Enhancement With Laser

The purpose of this clinical trial is to evaluate whether non-ablative Er:YAG laser treatment can improve decreased clitoral sensitivity in adult women who report this concern. Effectiveness and safety will be assessed after each laser session and again at a 2-month follow-up visit.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Uroclinica

Mendoza, Argentina

About this study

This study is designed to investigate whether non-ablative Er:YAG laser treatment can improve clitoral sensitivity in adult women who report decreased sensitivity. Reduced clitoral sensitivity can negatively impact sexual response, orgasm, and quality of life, yet effective treatment options are limited.

The primary goal of this clinical trial is to determine the effectiveness and safety of non-ablative Er:YAG laser treatment for women experiencing decreased clitoral sensitivity. Specifically, the study aims to assess:

The degree to which laser treatment enhances vaginal and clitoral sexual response, the time required to achieve noticeable improvements in sexual response, the impact of treatment on orgasmic function and patient satisfaction with the treatment process and outcomes.

Participants will undergo three laser treatment sessions, with evaluations conducted at a 2-month follow-up. Both effectiveness (improvements in sexual response and satisfaction) and safety outcomes will be carefully monitored.

By exploring this minimally-invasive therapeutic option, the study seeks to provide new insights into the management of decreased clitoral sensitivity and to help identify safe and effective approaches for improving sexual health in women.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • above 18 years
  • sexually active at least once per month

Exclusion criteria

  • anorgasmia
  • pregnancy
  • urinary tract infections
  • genital infectious diseases of other etiology (HPV, molluscum contagiosum, syphilis, HIV, etc.)
  • genital bleeding
  • collagenopathies
  • ongoing chemotherapy
  • active genital cancer
  • patients undergoing pelvic radiotherapy
  • any genital or extragenital pathology that may interfere with treatment
  • patients who have limitations in performing a follow-up to this study
  • patients with psychiatric disorders that may be difficult to treat
  • patients who have a contraindication to vaginal laser treatments

Treatment and study plan

Active therapy with non-ablative Er:YAG laser

Device

three intravaginal and vulvar/clitoral treatments within 60 days

Primary outcomes

  1. Change of bothersome symptoms (decreased intensity of clitoral/vaginal response, decreased time of good sexual response, decreased orgasm sensation)

    Time frame: Change from Baseline at 2 months after last intervention

    Evaluation of clitoral sensitivity change was performed 2 months after the last treatment session. Patients answered a five-point Likert scale (from 0 to 4) questionnaire.

Secondary outcomes

  1. Patient satisfaction with 5-point Likert scale

    Time frame: Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.

    Patients were asked to assess their global satisfaction with the treatment on a 5-point Likert scale (1-Very unsatisfied, 2-Unsatisfied, 3-Neutral, 4-Satisfied, 5-Very satisfied).

  2. Recording of frequency and severity of adverse effects related to laser treatment

    Time frame: From Baseline to 2 months after last intervention

    Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.

Sponsors and collaborators

Lead sponsor

Espacio Gaspar Clinic

Other

Registry information

Official study title

Clitoral Sensitivity Enhancement With Hyperstacking of Er:YAG SMOOTH Mode

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2025
Registry last updated
Sep 11, 2025

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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