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The Use of Laser in the Treatment of Atrophic Vulvovaginitis

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ClinicalTrials.gov Identifier: NCT04297319
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
CLAUDIA ESTER MARCHITELLI, Hospital Italiano de Buenos Aires

Brief Summary:
This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.

Condition or disease Intervention/treatment Phase
Lasers Atrophy of Vagina Atrophy Vulva Procedure: Laser diiodo Procedure: Laser Placebo Not Applicable

Detailed Description:
Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, randomized, control clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The patient and the outcomes assessor and principal investigator has not access to the randomization system
Primary Purpose: Treatment
Official Title: The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
Experimental: 1 - Laser intervention
Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks
Procedure: Laser diiodo
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.

Placebo Comparator: 2 - Laser placebo
Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks
Procedure: Laser Placebo
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.




Primary Outcome Measures :
  1. Change from Baseline in Female Sexual Function Index questionnaire [ Time Frame: baseline, and week 4 after treatment ]
    Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome

  2. Change from Baseline in Female Sexual Function Index questionnaire [ Time Frame: baseline,and week 12 after treatment ]
    Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome

  3. Change from Baseline in Female Sexual Function Index questionnaire [ Time Frame: baseline, and week 36 after treatment ]
    Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome

  4. Vaginal Cytology Improvement [ Time Frame: baseline, and week 4 after treatment ]
    Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy

  5. Vaginal Cytology Improvement [ Time Frame: baseline, and week 12 after treatment ]
    Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy

  6. Vaginal Cytology Improvement [ Time Frame: baseline, and week 36 after treatment ]
    Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy

  7. Change in vaginal acidity measure [ Time Frame: baseline, and week 4 after treatment ]
    the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)

  8. Change in vaginal acidity measure [ Time Frame: baseline, and week 12 after treatment ]
    the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)

  9. Change in vaginal pH measure [ Time Frame: baseline,and week 36 after treatment ]
    the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)


Secondary Outcome Measures :
  1. Number of patient with Local Estrogen therapy requirement post intervention [ Time Frame: baseline,and week 48 ]
    Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question.


Other Outcome Measures:
  1. Number of participant with Adverse events reported in each visit [ Time Frame: Baseline,and week 48 ]
    It will be evaluate the number of patients that reported adverse events such as dyspareunia, irritation, edema, vaginal dryness, genital bleeding, vaginal discharge, pain, lesions



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Menopause women with vulvovaginal symptoms of atrophy
  • No previous estrogen treatment for the last 30 days
  • Active sexual life (vaginal penetration)
  • Accept to participate
  • Pap atrophy or hypotrophy in the last year

Exclusion Criteria:

  • Vulvovaginal diseases
  • Abnormal uterine bleeding
  • Antidepressants drugs
  • Uncontrolled diabetes
  • Cervical intraepithelial lesions or cancer
  • Photosensitized or under treatment with photosensibilized drugs
  • Collagen diseases
  • Vulvovaginal infections in the last 15 days
  • Immunosuppressed patients or under immunosuppressed treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297319


Contacts
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Contact: Claudia E Marchitelli, MD 00541149590200 ext 8440 claudia.marchitelli@hospitalitaliano.org.ar
Contact: Mariela Prada, MD 00541149590200 ext 8440 mariela.prada@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires Recruiting
Caba, Argentina, 1199
Contact: Claudia E marchitelli, MD    541149590200 ext 8440    claudia.marchitelli@hospitalitaliano.org.ar   
Contact: Mariela Prada, MD    54119590200 ext 8440    mariela.prada@hiba.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: claudia E Marchitelli, MD Hospital Italiano de Buenos Aires-Argentina.
Publications of Results:
Other Publications:
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Responsible Party: CLAUDIA ESTER MARCHITELLI, Chief of the Gynecology department, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT04297319    
Other Study ID Numbers: 5076
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vulvovaginitis
Atrophy
Pathological Conditions, Anatomical
Vaginitis
Vaginal Diseases
Vulvitis
Vulvar Diseases