Trial Search Results

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

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

El. En. SpA

Collaborator: Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Laser treatment

Phase:

N/A

Eligibility


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

Ages Eligible for Study

45 Years - 60 Years

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tine Bjornlund
650-724-7826
Recruiting