Cervical lesions can be caused by pathogens, hormonal changes or by cervical injury. The recommended treatment in all cases is excision. Local re‑epithelialization therapy should be initiated preoperatively and postoperatively. The present study assessed the post‑market performance and tolerability of Cerviron^® ovules in the treatment and management of cervical lesions postoperatively. The study population included 345 participants aged 20‑70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion. The degree of re‑epithelialization of the cervical mucosa was improved in 73.17% of the patients evaluated during routine colposcopy exams and 92.73% of patients recorded no bleeding. When adding Cerviron^® either as monotherapy or in association with other antimicrobials in postoperative care of the cervical ectropion, improved postoperative outcomes such as reduced post‑interventional bleeding and a superior quality of healing were observed. The study and its details are registered in www.clinicaltrials.gov under ID NCT05668806.

Nonspecific vaginitis is a distinct clinical entity with particular microscopic and immunologic features. There is currently no standard of care for women with nonspecific vaginitis. The aim of our study was to assess the change in vaginal symptoms score after 3 months of treatment with an intravaginal medical device in participants with abnormal vaginal discharge and specific signs and symptoms. As secondary objectives, the study analyzed other clinical and microscopic features, such as vaginal discharge aspect, change in vaginal pH, change in vaginal microbiome, and vaginal inflammation. The study population included 47 participants with symptomatic vulvovaginitis, distinct from candidiasis, trichomoniasis, or bacterial vaginosis. The study design included 2 research sites from Romania. The treatment protocol consisted of 1 ovule per day inserted intravaginally during 15 consecutive days. The total study duration was 3 months. The intravaginal medical device had a positive impact on the vaginal symptoms score for 72.34% of the study participants. Topical administration of the ovules balanced vaginal pH values and significantly reduced signs of inflammation between study visits. This intravaginal medical device had curative effects that support its use as a stand-alone treatment in women with nonspecific vaginitis. A second clinical investigation is ongoing to evaluate the clinical efficacy of the device in postoperative care of cervical and vaginal wounds traumatic or secondary to surgical interventions. gov identifier: NCT04735705.

Background: Palbociclib, when combined with endocrine therapy, represents a valuable treatment option for patients diagnosed with hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer (BC) or metastatic breast cancer (MBC). Approved in Europe following phase II/III trials, it became the first CDK4/6 inhibitor used alongside hormone therapy. Available real-world data demonstrate the strong performance of Palbociclib in unselected, heavily pretreated patient groups. Our retrospective, observational, multicenter study, conducted in six Romanian institutions during a follow-up period of 2.5 years, aimed to assess Palbociclib’s safety and effectiveness in clinical practice. Objectives: The primary endpoints included response rate such as overall response rate (ORR), duration of response (DOR), disease control rate (DCR) and best clinical response (BCR), progression free survival (PFS) and overall survival (OS). The secondary objectives focused on treatment duration with aromatase inhibitors (AI) or fulvestrant and subsequent therapies after disease progression. Grade 3/4 adverse events were individually recorded. Exploratory analysis evaluated the potential predictive biomarkers such as Ki67, lower levels of HER2 expression (HER2-low), and histological or luminal subtype. Methods: Approximately 650 patients were planned for inclusion. PFS and OS were analyzed via the Kaplan–Meier method, with median times, 1- and 2-year estimates, and 95% confidence intervals reported. Conclusions: This study supports the integration of clinical trial evidence into real-world settings, enhancing patient selection and treatment personalization.

Background: Laser conization and electrocautery are the preferred surgical options for the management of benign cervical erosions. Local re-epithelialization therapy should be initiated preoperatively and postoperatively to prevent severe bleeding, wound inflammation, and infection. Objective: To investigate the aspect of the cervix by colposcopy after a 3-month treatment with the medical device. As secondary objectives, the study analyzed the presence of primary and secondary inflammation, the presence of ulceration, colpitis, vaginal discharge, and vaginal irritation. Methods: The study population included 27 participants with benign, ectopic, cervical ectopy that consented their participation in 3 research sites from Romania. The treatment protocol consisted of the delivery of the medical device intravaginally, for 15 consecutive days, with a total study duration of 3 months. Results: Cerviron had a positive impact on cervical epithelialization. After 3 months of treatment with Cerviron, for 100.00% of the participants, the colposcopy result was normal. Cerviron seems to exert a beneficial effect in reducing primary inflammation correlated with cervical erosions. It was observed that after 90 days of treatment primary inflammation was reduced by 85.19% (p < 0.001; 95% CI [58.74 – 98.35]). Other clinical parameters associated with cervical ectopy have certainly improved: vaginal erosion by 70.37% (p < 0.001, 95% CI [48.30 – 93.23]), ulceration by 55.56% (p < 0.001, 95% CI [33.22 – 83.67]), colpitis by 81.48% (95% CI [62.52 – 100.00], and vaginal secretion by 66.67% (95% CI [44.26 – 90.74]). Conclusions: The medical device reduced inflammation and other symptoms related to non-malignant cervical disease. Moreover, our study findings suggest that supportive treatment with Cerviron can be recommended for cervical wound healing in patients with human papillomavirus infection. ClinicalTrials.gov identifier: NCT04735718

Decreasing estrogen levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse and decreased pelvic floor strength and control. Sexual dysfunction associated with vaginal dryness occurs in postmenopausal patients. The present study (trial no. NCT05654610) was designed as an observational, multicenter, real‑world clinical investigation to evaluate the performance and safety of the medical device Halova^® ovules in decreasing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova ovules, both in monotherapy and in combination with vaginal lubricants. The primary objective was to evaluate the tolerability of Halova ovules in the management of symptoms associated with perimenopause or genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia and endometrial thickness was defined a secondary objective. Halova ovules were rated with ‘excellent’ clinical performance by 92.74% of participants as a standalone treatment and 95.71% of the study participants when used in association with vaginal lubricants. Sexual dysfunction‑associated parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm, 82% (monotherapy) and 80% (polytherapy) for vaginal dryness and 72% in monotherapy vs. 48% polytherapy in reducing dyspareunia. No adverse reactions associated with treatment with Halova were reported. The medical device demonstrated anti‑atrophic activity in the genitourinary tract, resulting in significantly improved symptoms associated with normal sexual functioning.

Cervical lesions can be caused by pathogens, hormonal changes or by cervical injury. The recommended treatment in all cases is excision. Local re-epithelialization therapy should be initiated preoperatively and postoperatively. The present study assessed the post-market performance and tolerability of Cerviron ^® ovules in the treatment and management of cervical lesions postoperatively. The study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion. The degree of re-epithelialization of the cervical mucosa was improved in 73.17% of the patients evaluated during routine colposcopy exams and 92.73% of patients recorded no bleeding. When adding Cerviron ^® either as monotherapy or in association with other antimicrobials in postoperative care of the cervical ectropion, improved postoperative outcomes such as reduced post-interventional bleeding and a superior quality of healing were observed. The study and its details are registered in www.clinicaltrials.gov under ID NCT05668806 .