New combo treatment eases menopause symptoms without hormones
NCT ID NCT07246616
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new treatment for postmenopausal women with vaginal atrophy—a condition causing dryness, burning, and pain. Researchers combined CO₂ laser therapy with a collagen cream to see if it worked better than laser alone. Sixty women aged 35 to 75 took part, and the team measured symptom relief and changes in vaginal bacteria after 30 and 60 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Oct 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Postmenopausal women with absence of menstrual cycle for at least 12 months, diagnosed with vulvovaginal atrophy (VVA) and presenting with related symptoms such as dryness, introital and deep dyspareunia, bleeding during intercourse, itching, or burning related to the severity of VVA, whether spontaneous or drug-induced (radio- or chemotherapy), either with a single symptom or a combination thereof. * Age between 35 and 75 years; * Patients unresponsive or dissatisfied with previous topical estrogen therapy, or presenting contraindications to the use of local and/or systemic estrogens. * Previous negative Pap test performed within 3 years prior to study enrollment. Exclusion Criteria: * • Pregnancy or breastfeeding; * Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva; * Presence of active genital and/or urinary tract infection; * Relative or absolute dermatological contraindications to laser use; * Ongoing hormonal therapy (systemic or local); * Neurological and/or psychiatric disorders; * Chronic systemic autoimmune or metabolic diseases; * Refusal to provide informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UOC di Ostetricia e Ginecologia, Ospedale di Stato della Repubblica di San Marino, Istituto per la Sicurezza Sociale (ISS)
San Marino, Borgo Maggiore, 47893, San Marino
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