Regenerative Treatment of Female Genital Atrophy

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

Interventions

BIOLOGICAL

Mesotherapy with Autologous Platelet-Rich Plasma (PRP) to vulvovaginal area

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.

OTHER

Mesotherapy with saline solution

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.

BIOLOGICAL

Platelet-Poor Plasma Gel

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

Sponsors & Collaborators

• Portuguese National Funding Agency for Science, Research and Technology (FCT)

  collaborator UNKNOWN

• University of Minho

  collaborator OTHER

• Hospital Santo André - Centro Hospitalar de Leiria

  collaborator UNKNOWN

• AndreiaAntunes

  lead OTHER

Principal Investigators

• 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

• Maria S Guarino, PhD · IPL - Polytechnic University of Leiria, CitechCare - Center for Innovative Care and Health Technology

• Cristina Isabel Nogueira-Silva, PhD, Medical Doctor · Minho University Medical School, ICVS - Life and Health Sciences Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-04

Primary Completion

2025-06-18

Completion

2025-11-26

Countries

• Portugal

Study Locations