Regenerative Treatment of Female Genital Atrophy

What this trial studies

Vulvovaginal health is a key aspect of active and healthy aging for all women. Hormonal deprivation that occurs during menopause significantly affects the anatomy and function of urogenital tissues, leading to their atrophy. Vaginal creams and suppositories containing estrogens are the standard treatment and can improve this condition. However, they require continuous application, which often makes adherence to treatment challenging.

Conditions in scope

• Vulvo Vaginal Atrophy

Interventions

• Mesotherapy with Autologous Platelet-Rich Plasma (PRP) to vulvovaginal area (Biological) — Intervention: Autologous Platelet-Rich Plasma Injection Type: Biological Description: Autologous PRP is prepared from peripheral venous blood collected into sterile citrate-containing PRP tubes with cell-separator gel. Samples are centrifuged at 3400 rpm (1200 g) for 7 minutes at room temperature. Platelet-poor…
• Mesotherapy with saline solution (Other) — Description: Participants receive intradermal injections of 2 ml sterile saline solution into the vulvar vestibule following the same injection sites, technique, needle size, and procedural steps as the PRP group. Six injections are administered using a linear retrograde technique, followed…
• Platelet-Poor Plasma Gel (Biological) — Description: Activated platelet-poor plasma gel is applied topically to the vulvar area using a cotton swab twice daily for five days following the procedure. This intervention is administered to participants in both study arms

Who can join

Women only · Ages 25 Years to 80 Years

Inclusion criteria

• At least one clinical complaint of VVA.
• Dryness
• Burning
• Itching
• Discomfort (soreness, irritation)
• Dyspareunia (sexual impaired function)
• With or without urinary problems (incontinence, urgency, dysuria). Must report a contra-indication with the standard local hormonal treatment.
• Allergy

Exclusion criteria

• Life expectancy \< 6 months due to concomitant illnesses.
• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
• Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status.
• Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
• Patients on chronic immunosuppressive transplant therapy.
• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
• Used oral, transdermal, vaginal, intrauterine, implants/injectables drugs that contained either oestrogens, progestins, androgens, or selective oestrogen receptor modulators (SERMs) before the study (a washout period of 4 weeks is required). Use of prescription and non-prescription medications and remedies known to alleviate VVA, discomfort including vaginal lubricants and moisturizers, are allowed during the study.
• Any allergic reaction to local anaesthetics.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE1, PHASE2
• Start date: 2024-06-04
• Primary completion: 2025-06-18
• Last update posted: 2025-12-31
• First posted: 2025-12-29

Sponsor & contact

Lead sponsor: AndreiaAntunes (Other)

Collaborators: Portuguese National Funding Agency for Science, Research and Technology (FCT), University of Minho, Hospital Santo André - Centro Hospitalar de Leiria

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Efficacy of PRP treatment (• T0 (Baseline): Initial evaluation • T1 (1 Month): 1ª treatment. • T2 (2 Months): 2º treatment. • T3 (3 Months): Follow-up evaluation • T4 (6 Months): Final evaluation, including symptom assessment, quality of life questionnaires, and laboratory tests.)
  Using SPSS software (version 26.0), the following statistical methods will be applied: * Descriptive Statistics: Means, standard deviations, frequencies, and percentages will summarize demographic and clinical characteristics. * Linear Mixed Models (LMMs): Used to evaluate changes in outcomes over time, controlling for assessment time and baseline characteristics. Adjusted means and 95% confidence interval. * Significance Testing: A p-value \<0.05 will…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.