Regenerative Treatment of Female Genital Atrophy

NCT07306611 | Completed Phase 1 DMC

• 2 other identifiers: 27/2024 CE ULS-RLPHD SCHOLARSHIP 2021. 07973.BD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. Additionally, women with hormone-dependent tumors, such as most breast cancers and many gynecological cancers, are even more affected by this issue. These women are often treated with anti-estrogen medications, undergo radio or chemotherapy, and are frequently younger, with the added complication that the standard treatment is contraindicated for them. To address this important issue, the study titled "Regenerative Treatment of Female Genital Atrophy" was developed. If you meet the required criteria, we would like to invite you to participate. Inclusion Criteria:

• Clinical complaints of genital atrophy (e.g., dryness, burning, itching, discomfort, or pain during intercourse).
• Contraindication to standard local hormonal treatment (e.g., allergy, bothersome side effects, lack of improvement with standard treatment, history of hormone-dependent cancer, or thrombotic event treated at least two years ago). This study focuses on Regenerative Medicine, which aims to support the regeneration of cells, tissues, or organs in the human body to restore normal function. This field holds significant curative and preventive potential. The selected regenerative treatment, widely used in various medical fields (such as dentistry and orthopedics), is derived from the patient's own body, making it a natural and safe option with minimal side effects. This treatment, known as platelet-rich plasma (PRP), has shown effectiveness in improving the firmness, elasticity, hydration, and thickness of the vulva and vagina. However, further research is required to assess the effectiveness of PRP specifically in the external female genital area. What is PRP - Platelet-Rich Plasma? PRP is a substance obtained from the patient's own blood. Blood is composed of several components, including red blood cells, white blood cells, plasma, and platelets. Platelets are small cell fragments that play a crucial role in blood clotting and wound healing. PRP is created by taking a small sample of the patient's blood and processing it in a centrifuge to concentrate the platelets within the plasma. This concentrated plasma, rich in growth factors and proteins, is then injected into the target area to stimulate tissue regeneration and repair. Because PRP is derived from the patient's own body, it is considered a natural and safe treatment with a very low risk of adverse reactions. PRP is obtained by collecting a small amount of the patient's blood. After a carefully standardized preparation process, the PRP is injected into the vulvovaginal area under local anesthesia. Study Location: Gynecology Department of Santo André Hospital, Leiria, at the Genital Atrophy Clinic. Study Protocol:
• Initial evaluation consultation.
• First treatment intervention.
• Follow up approximately one month after the first treatment and second treatment intervention.
• Another follow-up approximately one month after the second treatment.
• Final evaluation six months after the start of the study. Participants are divided into two groups: one group receives PRP treatment, while the other receives a placebo (serum). At the end of the study, participants in the placebo group will have the option to undergo PRP treatment. This is a double-blind study designed to evaluate the efficacy of PRP in the female external genital area.

Conditions

Vulvo Vaginal Atrophy

Keywords

Vulvovaginal atrophy; menopause; Ageing; regenerative treatment; platelets-rich plasma; autologous plasma

Outcome Measures

Primary Outcomes (1)

• Efficacy of PRP treatment

  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 be considered statistically significant. * Effect Size: Standardized treatment effect will be calculated as the mean difference in change between T0 and T4, divided by the standard deviation (SD) of that difference. Effect sizes will be categorized as small (0.2), medium (0.5), or large (0.8). A statistically significant improvement of VVA symptoms self-identified by subjects at baseline and a significant perception of improvement of quantitative assessment of genital health with the VVET scale .

  • 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.

Secondary Outcomes (1)

• Validation of a clinical Tool to visually classifying the severity of VVA and the characterization of the vulvovaginal area.

  • T0 (Baseline): Initial evaluation • T3 (3 Months): Follow-up evaluation. • T4 (6 Months): Final evaluation

Study Arms (2)

PRP Group

ACTIVE COMPARATOR

GROUP A (18 patients) random assign from enrolled patients: Participants receive intradermal injections of autologous platelet-rich plasma (PRP) into the vulvar vestibule, followed by topical application of platelet-poor plasma (PPP) gel for 5 days.

Biological: Mesotherapy with Autologous Platelet-Rich Plasma (PRP) to vulvovaginal area; Biological: Platelet-Poor Plasma Gel

Placebo Group

PLACEBO COMPARATOR

GROUP B (12 patients) random assign from enrolled patients: Participants receive intradermal injections of saline solution into the vulvar vestibule, followed by topical application of platelet-poor plasma (PPP) gel for 5 days.

Other: Mesotherapy with saline solution; Biological: Platelet-Poor Plasma Gel

Interventions

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 by local compression and topical PPP gel application twice daily for 5 days.

Placebo Group

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 plasma (PPP) is separated and activated with calcium gluconate to obtain a topical gel. PRP is obtained by releasing platelets from the gel and aspirating the platelet-enriched plasma. After vulvar disinfection and topical anesthesia, 2 ml of PRP is injected intradermally using a 27-gauge, 13 mm needle. Six injections are administered along the vulvar vestibule (anterior, posterior, and bilateral lateral sites) using a linear retrograde technique. Local compression is applied for one minute. Participants apply PPP gel twice daily for 5 days.

PRP Group

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

PRP Group; Placebo Group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Burden side effects
• Non-improvement with standard treatment
• Hormonal cancer survivors must be in remission for two years after the last oncologic treatment.
• Thrombotic disease patients must have the disease controlled and have passed 2 years after the thrombotic event.
• Must have a cervicovaginal cytology confirming the atrophy, having ≤ 5% of superficial cells on vaginal smear. Moreover, a normal morphologic cytology besides the inflammatory or atrophy change is mandatory.
• Must have a vaginal pH above 5 at baseline. Must have a normal mammography (American College of Radiology BI-RADS 1 or 2) within 12 months of study starts (Day 1), and normal breast examination.
• Willing to participate in the study and sign an informed consent.

You may not qualify if:

• 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.
• Unwilling and/or not able to give written informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Santo André Hospital

Leiria, Leiria District, 2410-197, Portugal

Location

Related Publications (43)

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MeSH Terms

Interventions

Mesotherapy; Saline Solution

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andreia R Antunes, PhD Student and Medical Doctor

  Minho University Medical School, ICVS - Life and Health Sciences Research Institute, IPL - Polytechnic University of Leiria, CitechCare - Center for Innovative Care and Health Technology, Local Health Unit of Leiria Region, Santo André Hospital

  PRINCIPAL INVESTIGATOR

• Maria S Guarino, PhD

  IPL - Polytechnic University of Leiria, CitechCare - Center for Innovative Care and Health Technology

  STUDY DIRECTOR

• Cristina Isabel Nogueira-Silva, PhD, Medical Doctor

  Minho University Medical School, ICVS - Life and Health Sciences Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: affiliated investigator, PhD Student, Consultant of Gynecology and Obstetrics

Model Details: The sample is adult women aged 25-80 years followed at the gynecology appointment of ULS RL. Potential participants (n= 30) were enrolled at specific gynecology consultation of genital atrophy at the ULS RL. We considered an N=30 because this is the minimum number of individuals according to the central limit theorem to obtain a normal Gaussian distribution of the sample. This was a randomized controlled trial using a random number table in two treatment groups (PRP versus placebo-saline solution), Participants were randomized in a 3:2 ratio to receive either the active treatment or placebo. A computer-generated randomization list containing 30 assignments (18 treatment and 12 placebo) was created using simple randomization without replacement. Each participant was assigned the next sequence was generated before participant enrollment and kept concealed from investigators. Several measures were collected to obtaining statistically robust estimates.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: June 4, 2024
• Primary Completion: June 18, 2025
• Study Completion: November 26, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)