Atrophic VulvovaginitisNCT06978907
Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) With Vaginal Laser Therapy in Menopausal Women With Atrophic Vulvovaginitis (VVA)
A study testing Monnalisa Touch® Laser Therapy and Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®) in people with Atrophic Vulvovaginitis, run by Liaquat University of Medical & Health Sciences at 2 sites in Italy.
Trial summary
This randomized, controlled, prospective, multicenter study aims to evaluate the efficacy and safety of Lactobacillus crispatus M247 in combination with vaginal laser therapy for improving vaginal microbiota composition and reducing genitourinary symptoms in menopausal women with atrophic vulvovaginitis (VVA). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Atrophic Vulvovaginitis
- What is being tested?
- Monnalisa Touch® Laser Therapy and Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2025to 9 Dec 2025
- Phase
- Interventional
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal women with no menstrual cycle for >12 months.
- Diagnosed with atrophic vulvovaginitis (VVA) and experiencing related symptoms (vaginal dryness, introital and profound dyspareunia, itching, burning, bleeding during intercourse).
- Symptoms related to genitourinary syndrome of menopause (GSM), including urinary urgency, increased frequency, nocturia, recurrent cystitis, or post-coital cystitis.
- Prior negative PAP test performed within one year of enrollment.
- Women who are unresponsive to or dissatisfied with prior topical estrogen therapy or who have contraindications to local and/or systemic estrogen prescription.
Who cannot join
- Pregnancy or breastfeeding.
- Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva.
- Active genital and/or urinary tract infections.
- Dermatological contraindications to laser therapy.
- Ongoing systemic or local hormone therapy.
- Neurological or psychiatric disorders.
- Chronic systemic diseases of autoimmune or dysmetabolic nature.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Villa Margherita Clinic
Roma, 00161
Hospital State of Republic of San Marino
San Mariano, 47893
About this study
Official title: Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) in Combination With Vaginal Laser Therapy for Improving Vaginal Microbiota Composition and Symptomatology in Menopausal Women With Atrophic Vulvovaginitis: A Prospective, Multicenter, Randomized, Controlled Clinical Trial
This randomized, controlled, prospective, multicenter study aims to evaluate the efficacy and safety of Lactobacillus crispatus M247 in combination with vaginal laser therapy for improving vaginal microbiota composition and reducing genitourinary symptoms in menopausal women with atrophic vulvovaginitis (VVA). Participants will be randomized into two groups: one receiving laser therapy alone and the other receiving laser therapy combined with daily administration of the probiotic Lactobacillus crispatus M247 (Crispact®). Primary outcomes include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety. Secondary outcomes include changes in vaginal microbiota composition.
Read the detailed description
Atrophic vulvovaginitis (VVA) is a common condition affecting menopausal women, characterized by symptoms such as vaginal dryness, dyspareunia, itching, and recurrent urinary tract infections. These symptoms result from decreased estrogen levels leading to an imbalance in vaginal microbiota. Standard treatments for VVA include hormonal therapy, but this approach is often associated with adverse effects and contraindications.
This study investigates a non-hormonal approach using Lactobacillus crispatus M247 (Crispact®), a probiotic strain known for its ability to maintain a healthy vaginal microbiota, in combination with vaginal laser therapy. The study will include 75 menopausal women diagnosed with VVA who will be randomized in a 2:1 ratio, with a greater proportion allocated to the laser-only group and the remaining participants receiving laser therapy combined with the probiotic.
Primary outcomes will include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety over the study period. Secondary outcomes will include changes in vaginal microbiota composition, including Lactobacillus crispatus levels, assessed at baseline (T0) and three months (T3).
The study is approved by the Ethics Committee for Human Experimentation (CESU), University of Urbino Carlo Bo, under protocol 124_6March2025_Lactobacillus crispatus M247_Sisti, on 29.04.2025.
- Conditions
- Atrophic Vulvovaginitis
- Being tested
- Monnalisa Touch® Laser Therapy, Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monnalisa Touch® Laser TherapyDevice
Also called Vaginal Laser Therapy
Monnalisa Touch® laser therapy is a non-ablative fractional CO2 laser applied to the vaginal mucosa to promote tissue regeneration and maintain vaginal health. Participants in this group will receive three sessions of laser therapy, one session every 30 days.
Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)Combination product
Also called Laser + Probiotic Therapy
Participants in this group will receive three sessions of Monnalisa Touch® laser therapy, one session every 30 days, along with daily administration of Lactobacillus crispatus M247 (Crispact®), a probiotic containing 20 billion CFU, taken orally for three months.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Laser Therapy Only | Active comparator | Participants in this arm will receive three sessions of vaginal laser therapy (Monnalisa Touch® laser), administered once every 30 days. Receives: Device: Monnalisa Touch® Laser Therapy |
| Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic | Experimental | Participants in this arm will receive three sessions of vaginal laser therapy (Monnalisa Touch® laser), administered once every 30 days, in combination with daily administration of Lactobacillus crispatus M247 probiotic (Crispact®) containing 20 billion CFU, taken orally once daily for three months. Receives: Device: Monnalisa Touch® Laser Therapy; Combination Product: Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Genitourinary Symptoms
Assessment using the Vulvovaginal Atrophy Symptom Questionnaire (VASQ), evaluating symptom severity (e.g., vaginal dryness, itching, dyspareunia, urinary symptoms) from baseline (T0) to Month 3 (M3).
Measured: Baseline (T0) to Month 3 (M3).
Safety Assessment
Evaluation of safety and tolerability of Lactobacillus crispatus M247 based on the incidence of adverse events throughout the study period (Baseline to Month 3).
Measured: Baseline (T0) to Month 3 (M3).
Secondary outcomes (1)
Change in Vaginal Microbiota Composition (Lactobacillus crispatus Abundance)
Assessment of the change in the abundance of Lactobacillus crispatus in the vaginal microbiota, measured using vaginal swab samples analyzed at baseline (T0) and after 3 months (T3).
Measured: Baseline (T0) and 3 months (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jul 2025
- Primary completion27 Nov 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrophic VulvovaginitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two groups in a 2:1 (Laser-only : Laser + Crispact) Group 1: Vaginal laser therapy only. Group 2: Vaginal laser therapy + Lactobacillus crispatus M247 (Crispact®) probiotic.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978907
- Sponsor's protocol ID
- L. crispatus M247/25.04.2025
- Status last verified
- Jan 2026
- First submitted
- 11 May 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aldunate M, Srbinovski D, Hearps AC, Latham CF, Ramsland PA, Gugasyan R, Cone RA, Tachedjian G. Antimicrobial and immune modulatory effects of lactic acid and short chain fatty acids produced by vaginal microbiota associated with eubiosis and bacterial vaginosis. Front Physiol. 2015 Jun 2;6:164. doi: 10.3389/fphys.2015.00164. eCollection 2015.
PubMed 26082720Asgharpoor H, Hadizadeh-Talasaz F, Rahmani R, Rakhshandeh H, Rahmati Z. The Effect of Citrus Aurantium Vaginal Cream on Vaginal Atrophy in Postmenopausal Women: A Quasi-experimental Study. Int J Community Based Nurs Midwifery. 2024 Jan 1;12(1):32-43. doi: 10.30476/IJCBNM.2023.98670.2251. eCollection 2024 Jan.
PubMed 38328013De Seta F, Caruso S, Di Lorenzo G, Romano F, Mirandola M, Nappi RE. Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study. Maturitas. 2021 May;147:34-40. doi: 10.1016/j.maturitas.2021.03.002. Epub 2021 Mar 4.
PubMed 33832645Lubian-Lopez DM, Butron-Hinojo CA, Menjon-Beltran S, Gonzalez-Mesa E, Tapiador-Albertos S, Rodriguez-Jimenez B, Fiol-Ruiz G. Effects of Non-Ablative Solid-State Vaginal Laser (SSVL) for the Treatment of Vulvovaginal Atrophy in Breast Cancer Survivors after Adjuvant Aromatase Inhibitor Therapy: Preliminary Results. J Clin Med. 2023 Aug 31;12(17):5669. doi: 10.3390/jcm12175669.
PubMed 37685736Mitchell CM, Srinivasan S, Plantinga A, Wu MC, Reed SD, Guthrie KA, LaCroix AZ, Fiedler T, Munch M, Liu C, Hoffman NG, Blair IA, Newton K, Freeman EW, Joffe H, Cohen L, Fredricks DN. Associations between improvement in genitourinary symptoms of menopause and changes in the vaginal ecosystem. Menopause. 2018 May;25(5):500-507. doi: 10.1097/GME.0000000000001037.
PubMed 29206774Muhleisen AL, Herbst-Kralovetz MM. Menopause and the vaginal microbiome. Maturitas. 2016 Sep;91:42-50. doi: 10.1016/j.maturitas.2016.05.015. Epub 2016 Jun 1.
PubMed 27451320
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Lactobacillus Crispatus M247 (Crispact®) in Combination With Vaginal Laser Therapy for Improving Vaginal Microbiota Composition and Symptomatology in Menopausal Women With Atrophic Vulvovaginitis: A Prospective, Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06978907
- Acronym / sponsor ID
- L. crispatus M247/25.04.2025
- Conditions
- Atrophic Vulvovaginitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 18 May 2025 (actual)
- 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.
This randomized, controlled, prospective, multicenter study aims to evaluate the efficacy and safety of Lactobacillus crispatus M247 in combination with vaginal laser therapy for improving vaginal microbiota composition and reducing genitourinary symptoms in menopausal women with atrophic vulvovaginitis (VVA). Participants will be randomized into two groups: one receiving laser therapy alone and the other receiving laser therapy combined with daily administration of the probiotic Lactobacillus crispatus M247 (Crispact®). Primary outcomes include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety. Secondary outcomes include changes in vaginal microbiota composition.
Detailed description
Atrophic vulvovaginitis (VVA) is a common condition affecting menopausal women, characterized by symptoms such as vaginal dryness, dyspareunia, itching, and recurrent urinary tract infections. These symptoms result from decreased estrogen levels leading to an imbalance in vaginal microbiota. Standard treatments for VVA include hormonal therapy, but this approach is often associated with adverse effects and contraindications.
This study investigates a non-hormonal approach using Lactobacillus crispatus M247 (Crispact®), a probiotic strain known for its ability to maintain a healthy vaginal microbiota, in combination with vaginal laser therapy. The study will include 75 menopausal women diagnosed with VVA who will be randomized in a 2:1 ratio, with a greater proportion allocated to the laser-only group and the remaining participants receiving laser therapy combined with the probiotic.
Primary outcomes will include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety over the study period. Secondary outcomes will include changes in vaginal microbiota composition, including Lactobacillus crispatus levels, assessed at baseline (T0) and three months (T3).
The study is approved by the Ethics Committee for Human Experimentation (CESU), University of Urbino Carlo Bo, under protocol 124_6March2025_Lactobacillus crispatus M247_Sisti, on 29.04.2025.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two groups in a 2:1 (Laser-only : Laser + Crispact) Group 1: Vaginal laser therapy only. Group 2: Vaginal laser therapy + Lactobacillus crispatus M247 (Crispact®) probiotic.
| Arm | Type | Receives |
|---|---|---|
| Vaginal Laser Therapy Only | Active comparator | Device: Monnalisa Touch® Laser TherapyParticipants in this arm will receive three sessions of vaginal laser therapy (Monnalisa Touch® laser), administered once every 30 days. |
| Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic | Experimental | Device: Monnalisa Touch® Laser Therapy, Combination Product: Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)Participants in this arm will receive three sessions of vaginal laser therapy (Monnalisa Touch® laser), administered once every 30 days, in combination with daily administration of Lactobacillus crispatus M247 probiotic (Crispact®) containing 20 billion CFU, taken orally once daily for three months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Menopausal women with no menstrual cycle for >12 months.
- Diagnosed with atrophic vulvovaginitis (VVA) and experiencing related symptoms (vaginal dryness, introital and profound dyspareunia, itching, burning, bleeding during intercourse).
- Symptoms related to genitourinary syndrome of menopause (GSM), including urinary urgency, increased frequency, nocturia, recurrent cystitis, or post-coital cystitis.
- Prior negative PAP test performed within one year of enrollment.
- Women who are unresponsive to or dissatisfied with prior topical estrogen therapy or who have contraindications to local and/or systemic estrogen prescription.
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding.
- Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva.
- Active genital and/or urinary tract infections.
- Dermatological contraindications to laser therapy.
- Ongoing systemic or local hormone therapy.
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 |
|---|---|---|
| Monnalisa Touch® Laser TherapyAlso: Vaginal Laser TherapyMonnalisa Touch® laser therapy is a non-ablative fractional CO2 laser applied to the vaginal mucosa to promote tissue regeneration and maintain vaginal health. Participants in this group will receive three sessions of laser therapy, one session every 30 days. | Device | Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic, Vaginal Laser Therapy Only |
| Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)Also: Laser + Probiotic TherapyParticipants in this group will receive three sessions of Monnalisa Touch® laser therapy, one session every 30 days, along with daily administration of Lactobacillus crispatus M247 (Crispact®), a probiotic containing 20 billion CFU, taken orally for three months. | Combination product | Vaginal Laser Therapy + Lactobacillus crispatus M247 Probiotic |
Primary outcome
Change in Genitourinary Symptoms
Time frame: Baseline (T0) to Month 3 (M3).
Assessment using the Vulvovaginal Atrophy Symptom Questionnaire (VASQ), evaluating symptom severity (e.g., vaginal dryness, itching, dyspareunia, urinary symptoms) from baseline (T0) to Month 3 (M3).
Safety Assessment
Time frame: Baseline (T0) to Month 3 (M3).
Evaluation of safety and tolerability of Lactobacillus crispatus M247 based on the incidence of adverse events throughout the study period (Baseline to Month 3).
1 secondary outcome
Change in Vaginal Microbiota Composition (Lactobacillus crispatus Abundance)
Time frame: Baseline (T0) and 3 months (T3).
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 6 Jan 2026.
- Background: PubMed 26082720Aldunate M, Srbinovski D, Hearps AC, Latham CF, Ramsland PA, Gugasyan R, Cone RA, Tachedjian G. Antimicrobial and immune modulatory effects of lactic acid and short chain fatty acids produced by vaginal microbiota associated with eubiosis and bacterial vaginosis. Front Physiol. 2015 Jun 2;6:164. doi: 10.3389/fphys.2015.00164. eCollection 2015.
- Background: PubMed 38328013Asgharpoor H, Hadizadeh-Talasaz F, Rahmani R, Rakhshandeh H, Rahmati Z. The Effect of Citrus Aurantium Vaginal Cream on Vaginal Atrophy in Postmenopausal Women: A Quasi-experimental Study. Int J Community Based Nurs Midwifery. 2024 Jan 1;12(1):32-43. doi: 10.30476/IJCBNM.2023.98670.2251. eCollection 2024 Jan.
- Background: PubMed 33832645De Seta F, Caruso S, Di Lorenzo G, Romano F, Mirandola M, Nappi RE. Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study. Maturitas. 2021 May;147:34-40. doi: 10.1016/j.maturitas.2021.03.002. Epub 2021 Mar 4.
- Background: PubMed 37685736Lubian-Lopez DM, Butron-Hinojo CA, Menjon-Beltran S, Gonzalez-Mesa E, Tapiador-Albertos S, Rodriguez-Jimenez B, Fiol-Ruiz G. Effects of Non-Ablative Solid-State Vaginal Laser (SSVL) for the Treatment of Vulvovaginal Atrophy in Breast Cancer Survivors after Adjuvant Aromatase Inhibitor Therapy: Preliminary Results. J Clin Med. 2023 Aug 31;12(17):5669. doi: 10.3390/jcm12175669.
- Background: PubMed 29206774Mitchell CM, Srinivasan S, Plantinga A, Wu MC, Reed SD, Guthrie KA, LaCroix AZ, Fiedler T, Munch M, Liu C, Hoffman NG, Blair IA, Newton K, Freeman EW, Joffe H, Cohen L, Fredricks DN. Associations between improvement in genitourinary symptoms of menopause and changes in the vaginal ecosystem. Menopause. 2018 May;25(5):500-507. doi: 10.1097/GME.0000000000001037.
- Background: PubMed 27451320Muhleisen AL, Herbst-Kralovetz MM. Menopause and the vaginal microbiome. Maturitas. 2016 Sep;91:42-50. doi: 10.1016/j.maturitas.2016.05.015. Epub 2016 Jun 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monnalisa Touch® Laser Therapy and Monnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®) in people with Atrophic Vulvovaginitis, run by Liaquat University of Medical & Health Sciences at 2 sites in Italy.
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 7 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 6 Jan 2026. 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 Italy. 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?
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 in Genitourinary Symptoms (time frame: Baseline (T0) to Month 3 (M3).). The study lists 2 primary outcomes in all. 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 NCT06978907, which also lists 6 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 6 Jan 2026.