Vulvovaginal AtrophyNCT02085980
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
A study testing Laser treatment in people with Vulvovaginal Atrophy, run by El. En. SpA at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University
Palo Alto, California, 94306
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
West Chester, Ohio, 45069
About this study
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).
Read the 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.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentDevice
The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Experimental | Laser Treatment Receives: Device: Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and at follow up visit at 12 months post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- El. En. SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Christ Hospital, Stanford University
- Responsible party
- Sponsor
- Investigators
- Mickey Karram, MK, Principal investigator, Hospital Physician, The Christ HospitalEric Sokol, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085980
- Sponsor's protocol ID
- ELEN13-VVA-MK01
- Status last verified
- Feb 2017
- First submitted
- 10 Mar 2014
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 12037029
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT02085980
- Acronym / sponsor ID
- ELEN13-VVA-MK01
- Conditions
- Vulvovaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- El. En. SpAIndustry (pharma, biotech, devices)
- Collaborators
- The Christ Hospital, Stanford University
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Experimental | Device: Laser treatmentLaser Treatment |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser treatmentThe laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece | Device | Laser Treatment |
Primary outcome
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
Time frame: Baseline and at follow up visit at 12 months post last treatment
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12037029van 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.
- Individual participant dataSharing planned: No
Related trials for Vulvovaginal Atrophy
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Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
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F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
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A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mickey Karram, MK principal investigator
Hospital Physician, The Christ Hospital
Eric Sokol, MD study director
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Vulvovaginal Atrophy, run by El. En. SpA at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline and at follow up visit at 12 months post last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.