Clinical trial NCT02085980: Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Official title: Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Lead sponsor: El. En. SpA
Sponsor class: INDUSTRY
Collaborators: name: The Christ Hospital
name: Stanford University
First posted: 2014-03-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline
timeFrame: Baseline and at follow up visit at 12 months post last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: West Chester
country: United States
facility: The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
state: Ohio
Study officials:
affiliation: Hospital Physician, The Christ Hospital
name: Mickey Karram, MK
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Eric Sokol, MD
role: STUDY_DIRECTOR
References:
citation: van der Laak JA, de Bie LM, de Leeuw H, de Wilde PC, Hanselaar AG. The effect of Replens on vaginal cytology in the treatment of postmenopausal atrophy: cytomorphology versus computerised cytometry. J Clin Pathol. 2002 Jun;55(6):446-51. doi: 10.1136/jcp.55.6.446.