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| Name | Class |
|---|---|
| The Christ Hospital | OTHER |
| Stanford University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment | Experimental | Laser Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser treatment | Device | The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS). | Baseline and at follow up visit at 12 months post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
• Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
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| Name | Affiliation | Role |
|---|---|---|
| Mickey Karram, MK | Hospital Physician, The Christ Hospital | Principal Investigator |
| Eric Sokol, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94306 | United States | ||
| The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12037029 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Treatment | Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Treatment | Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS). | Posted | Count of Participants | Participants | Baseline and at follow up visit at 12 months post last treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser Treatment | Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mickey Karram | The Christ Hospital - Cincinnati, OH | (513) 463-2500 | mickey.karram@thechristhospital.com |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| West Chester |
| Ohio |
| 45069 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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