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Erbium Laser for Treatment of Vaginal Laxity.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228679
Recruitment Status : Not yet recruiting
First Posted : January 14, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Brief Summary:
Patients with a primary complaint of vaginal laxity visiting a sexual dysfunction clinic at a tertiary medical center will undergo a series of 3 laser treatments and the affect of these treatments will be measure both by female sexual function index validated questionaires and by means of gynecological examination-the vaginal health index.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Device: Erbium laser Not Applicable

Detailed Description:

Patients suffering from vaginal laxity as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.

Patients will undergo a series of 3 laser treatments and the affect of these treatments will be measure both by female sexual function index validated questionaires and by means of gynecological examination-the vaginal health index.

Follow up after treatment cessation will be for 12 months post-treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Affect of Erbium Laser Treatments on Vaginal Laxity in Female Pre-menopausal Female Individuals.
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Erbium

Arm Intervention/treatment
Experimental: Erbium laser treatment
Women suffering from vaginal laxity undergoing laser treatments.
Device: Erbium laser
Erbium laser device




Primary Outcome Measures :
  1. Female sexual function index. [ Time Frame: From recruitment up to 15 months. ]
    Changes in the female sexual function index scores pre- and post-treatment. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is.

  2. Vaginal health index. [ Time Frame: From recruitment up to 15 months. ]
    Changes in the vaginal health index scores pre- and post-treatment. Minimal score is 5, maximal score is 25, the higher the score the healthier the vagina is considered to be.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women.
  • Women with vaginal laxity as a primary complaint.

Exclusion Criteria:

  • Vaginal bleeding of unknown source.
  • Repeated vaginal infections.
  • Known or suspected cervical pre-malignant neoplasia.

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): NCT04228679


Contacts
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Contact: Roy Lauterbach, MD +972-52-9432416 r_lauterbach@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam healthcare campus

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Responsible Party: ROY LAUTERBACH MD, Principal investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04228679    
Other Study ID Numbers: 0309-19-RMB
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 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