Vulvovaginal AtrophyPhase 3NCT02419729
Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
A Phase 3 study testing CO2 laser and Estrogen in people with Vulvovaginal Atrophy, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- CO2 laser and Estrogen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-65 women with amenorrhea for over 24 months.
- Clinical vaginal atrophy diagnosis.
Who cannot join
- BMI > 35.
- Previous use of oral estrogen therapy in the last 6 months.
- History or current diagnosis of cancer.
- Altered cervical smear in the last 12 months.
- Renal or hepatic insufficiency.
- Drug-induced menopause.
Show all 9Show fewer
- Previous use of steroids.
- Previous vaginal radiotherapy therapy.
- Vulvovaginitis.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Atencao a Saude da Mulher
São Bernardo do Campo, São Paulo, 09770-210
About this study
Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment.
Read the detailed description
Vulvovaginal atrophy (VVA) symptoms are strongly associated with declining ovarian function and estrogen levels in postmenopausal women, having a considerable impact on women's life quality. Topical hormonal therapy and hormonal replacement are widely used to alleviate VVA symptoms. In this context, minimal invasive fractional CO2 laser emerges as an alternative non-hormonal therapy, especially in patients that present contraindications to hormonal therapy. Objective: Compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for VVA and determine the efficacy and possible adverse effects CO2 laser treatment. Materials and Methods: Forty-five postmenopausal women will be randomized in three double-blinded groups of treatment consisting of CO2 laser and placebo of estrogen vaginal cream, placebo of CO2 laser and estrogen vaginal cream and CO2 laser and estrogen vaginal cream. Assessment of baseline characteristics and follow-up will be obtained through self-completion questionnaires (Female Sex Function Index, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Vulvovaginal Symptom Questionnaire and The Menopause-Specific Quality of Life (MENQOL)). Frost Index and Vaginal Health Index (VHI) are part of objective clinical and histologic analyses. Colposcopy, vaginal cytology and middle third lateral vaginal wall biopsy will also be performed at baseline and at week 17.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- CO2 laser, Estrogen, Placebo of Estrogen, Placebo of CO2 laser
- Keywords
- Vulvovaginal atrophy, Menopause, Fractional CO2 laser, Estrogen cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laserDevice
Also called Fractionated CO2 laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2)
EstrogenDrug
Also called Estriol 1mg
Topical estrogen cream treatment: Estriol 1mg daily.
Placebo of EstrogenDrug
Placebo of topical estrogen cream.
Placebo of CO2 laserDevice
Also called SMARTXIDE2 V2LR - Monalisa Touch - Deka Laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each applications using minimal parameters suggested by the laser's software but power of 0.5 W was stipulated for the placebo intervention and other parameters remained unchanged.
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser & Estrogen | Experimental | Effective fractional CO2 laser therapy and effective estrogen vaginal cream Receives: Device: CO2 laser; Drug: Estrogen |
| CO2 laser & Placebo of Estrogen | Active comparator | Effective fractional CO2 laser therapy and placebo of estrogen vaginal cream. Receives: Device: CO2 laser; Drug: Placebo of Estrogen |
| Placebo of CO2 laser & Estrogen | Sham comparator | Placebo fractional CO2 laser therapy and effective estrogen vaginal cream. Receives: Drug: Estrogen; Device: Placebo of CO2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Vulvovaginal Symptom Questionnaire
Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Measured: Baseline, week 10 and week 17
Secondary outcomes (3)
Vaginal Cytology Improvement
Vaginal cytology will be obtained from the middle third lateral vaginal wall in order to evaluate initial conditions of the vaginal wall and modifications after treatment. Frost Index, Karyopyknotic Index and Eosinophilic Index will be applied to each sample to measure improvement of vaginal atrophy.
Measured: Baseline, week 10 and week 17
Change from Baseline in Female Sex Function Index
Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Measured: Baseline, week 10 and week 17
Change from Baseline in The Menopause-Specific Quality of Life
The Menopause-Specific Quality of Life will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Measured: Baseline, week 10 and week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Lucia, Faculdade de Medicina do ABC
- Investigators
- Vera L da Cruz, MD, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419729
- Sponsor's protocol ID
- 39495014.0.0000.0082
- Status last verified
- Jun 2016
- First submitted
- 6 Apr 2015
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.
PubMed 25333211Society of Obstetricians and Gynaecologists of Canada. SOGC clinical practice guidelines. The detection and management of vaginal atrophy. Number 145, May 2004. Int J Gynaecol Obstet. 2005 Feb;88(2):222-8. doi: 10.1016/j.ijgo.2004.11.003.
PubMed 15779109Bachman GA. A new option for managing urogenital atrophy in post-menopausal women. Cont Obstet Gynecol 42, pp. 13-28.
Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.
PubMed 24605832Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT02419729
- Acronym / sponsor ID
- 39495014.0.0000.0082
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Vulvovaginal atrophy, Menopause, Fractional CO2 laser, Estrogen cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment.
Detailed description
Vulvovaginal atrophy (VVA) symptoms are strongly associated with declining ovarian function and estrogen levels in postmenopausal women, having a considerable impact on women's life quality. Topical hormonal therapy and hormonal replacement are widely used to alleviate VVA symptoms. In this context, minimal invasive fractional CO2 laser emerges as an alternative non-hormonal therapy, especially in patients that present contraindications to hormonal therapy. Objective: Compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for VVA and determine the efficacy and possible adverse effects CO2 laser treatment. Materials and Methods: Forty-five postmenopausal women will be randomized in three double-blinded groups of treatment consisting of CO2 laser and placebo of estrogen vaginal cream, placebo of CO2 laser and estrogen vaginal cream and CO2 laser and estrogen vaginal cream. Assessment of baseline characteristics and follow-up will be obtained through self-completion questionnaires (Female Sex Function Index, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Vulvovaginal Symptom Questionnaire and The Menopause-Specific Quality of Life (MENQOL)). Frost Index and Vaginal Health Index (VHI) are part of objective clinical and histologic analyses. Colposcopy, vaginal cytology and middle third lateral vaginal wall biopsy will also be performed at baseline and at week 17.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CO2 laser & Estrogen | Experimental | Device: CO2 laser, Drug: EstrogenEffective fractional CO2 laser therapy and effective estrogen vaginal cream |
| CO2 laser & Placebo of Estrogen | Active comparator | Device: CO2 laser, Drug: Placebo of EstrogenEffective fractional CO2 laser therapy and placebo of estrogen vaginal cream. |
| Placebo of CO2 laser & Estrogen | Sham comparator | Drug: Estrogen, Device: Placebo of CO2 laserPlacebo fractional CO2 laser therapy and effective estrogen vaginal cream. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 45-65 women with amenorrhea for over 24 months.
- Clinical vaginal atrophy diagnosis.
Key exclusion criteria (9 listed)
- BMI > 35.
- Previous use of oral estrogen therapy in the last 6 months.
- History or current diagnosis of cancer.
- Altered cervical smear in the last 12 months.
- Renal or hepatic insufficiency.
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 |
|---|---|---|
| CO2 laserAlso: Fractionated CO2 laserSMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2) | Device | CO2 laser & Estrogen, CO2 laser & Placebo of Estrogen |
| EstrogenAlso: Estriol 1mgTopical estrogen cream treatment: Estriol 1mg daily. | Drug | CO2 laser & Estrogen, Placebo of CO2 laser & Estrogen |
| Placebo of EstrogenPlacebo of topical estrogen cream. | Drug | CO2 laser & Placebo of Estrogen |
| Placebo of CO2 laserAlso: SMARTXIDE2 V2LR - Monalisa Touch - Deka LaserSMARTXIDE2 V2LR (DEKA-Pulse) was used in each applications using minimal parameters suggested by the laser's software but power of 0.5 W was stipulated for the placebo intervention and other parameters remained unchanged. | Device | Placebo of CO2 laser & Estrogen |
Primary outcome
Change from Baseline in Vulvovaginal Symptom Questionnaire
Time frame: Baseline, week 10 and week 17
Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.
3 secondary outcomes
Vaginal Cytology Improvement
Time frame: Baseline, week 10 and week 17
Change from Baseline in Female Sex Function Index
Time frame: Baseline, week 10 and week 17
Change from Baseline in The Menopause-Specific Quality of Life
Time frame: Baseline, week 10 and week 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Results publication: PubMed 25333211Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.
- Results publication: PubMed 15779109Society of Obstetricians and Gynaecologists of Canada. SOGC clinical practice guidelines. The detection and management of vaginal atrophy. Number 145, May 2004. Int J Gynaecol Obstet. 2005 Feb;88(2):222-8. doi: 10.1016/j.ijgo.2004.11.003.
- Results publicationBachman GA. A new option for managing urogenital atrophy in post-menopausal women. Cont Obstet Gynecol 42, pp. 13-28.
- Results publication: PubMed 24605832Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
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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.
Vera L da Cruz, MD principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CO2 laser and Estrogen in people with Vulvovaginal Atrophy, run by Faculdade de Medicina do ABC at 1 site in Brazil.
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 2 inclusion and 9 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 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Vulvovaginal Symptom Questionnaire (time frame: Baseline, week 10 and week 17). 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 NCT02419729, which also lists 5 linked publications.
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 28 Jun 2016.