Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit
Recruiting
Phase 4
Interventional Study
Genitourinary Syndrome of Menopause
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 192 (estimated)
- Sponsor
- Fundación Santiago Dexeus Font · Other
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About This Trial
This study is a randomized, controlled, non-inferiority trial, that will be performed on 192 women on Menopause (absence of menstruation for at least 12 months), with diagnostic of genitourinary syndrome of menopause (SGM) and a vaginal health index \<15 points, that are sexually active.
Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatme…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women ≤70 years old
* Women that are sexually active
* Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) \< 15 points.
* Women who understand the Spanish language
* Willing to participate in the study and sign informed consent.
Ex…
Contacts