Evaluating the effect of a vaginal product containing Cucurbita pepo L. subsp. pepo fruit (green zucchini morphotype) compared to Vagisoft cream on subjective symptoms of vulvovaginal atrophy in women with breast cancer

Start Date20 Apr 2024

Sponsor / Collaborator

Shahid Beheshti University of Medical Sciences

100 Clinical Results associated with Postmenopausal atrophic vaginitis

100 Translational Medicine associated with Postmenopausal atrophic vaginitis

0 Patents (Medical) associated with Postmenopausal atrophic vaginitis

120

Literatures (Medical) associated with Postmenopausal atrophic vaginitis

01 Oct 2024·Geburtshilfe und Frauenheilkunde

Effects of Progesterone on Vasomotor Symptoms in Postmenopausal Women (PROGEST) – a Prospective Multi-Center Randomized Double-Blind Placebo-Controlled Trial (RDPCT)

Article

Author: Tropschuh, Katharina Victoria ; Beinert, Sissi Valentina ; Kleinsorge, Frauke ; Worm, Julia ; Seifert-Klauss, Vanadin

Abstract Introduction Monotherapy with progesterone for treatment of vasomotor symptoms (VMS) was more effective than placebo treatment of postmenopausal healthy women in a Canadian trial. The PROGEST-trial was initiated to fulfill FDA-approval criteria for the indication of treatment of postmenopausal VMS. Methods This prospective randomized, double-blind placebo-controlled clinical trial studied three doses of oral micronized progesterone (200 mg, 300 mg, 400 mg) and placebo for 12 weeks. Postmenopausal women with moderate to severe VMS (> 50 per week) were screened for one week for VMS frequency, then randomized to 200, 300 or 400 mg progesterone daily or placebo for a double-blinded trial of 12 weeks duration. Results 74 women were recruited in 12 study centers. 44 terminated the study as per protocol (PP). Moderate to severe hot flushes decreased by 7.4/d in the placebo arm, 7.7 VMS/d with 200 mg/d progesterone (P4), 8.3 VMS/d on 300 mg/d and 9.0 VMS/d on 400 mg/d P4, respectively by week 12. 32 treatment emergent adverse events were documented in 18 participants, mostly minor AEs. The only SAE was a syncope requiring hospitalization on the day after treatment initiation, leading to discontinuation of the drug. Discussion Baseline VMS frequency was much higher in the German than in the Canadian study and the course of the placebo group had a markedly stronger decrease in VMS-frequency during the PROGEST study (−7.4/d) than in the Canadian trial (−1.4/d). Trial populations differed by age, BMI, the number of women with natural menopause, and comorbidities, mainly hypertension. Conclusion Premature discontinuation of the trial due to insufficient subject accrual rate led to only 55 randomized participants for analysis, therefore the study results lack statistical power. Still, a slight dose-dependent improvement in VMS was seen for all doses, while AE frequency did not increase with progesterone dose.

31 May 2024·Medicine

The effect of predictive nursing on the mental state, compliance and sleep quality of senile cervicitis: An observational study

Article

Author: Rao, Danfeng ; Chen, Xiangxiang ; Zhang, Xiuge ; Chen, Jing ; Yu, Qian ; Chen, Xiaoxue ; Li, Feng

To explore the effect of predictive nursing on the mental state, compliance and sleep quality of elderly patients with cervicitis. The clinical data of 96 elderly patients with cervicitis who were admitted to our hospital from June 2019 to June 2021 were selected as the research objects. According to the different treatments, they were divided into a control group and an observation group with 48 cases each. Among them, the control group was given routine care, and the observation group was given predictive care on the basis of the control group. The effects of the quality of life, mental state, compliance and sleep quality of the 2 groups of patients before and after nursing were compared. Comparing the nursing compliance of the 2 groups of elderly patients with cervicitis, statistics showed that the difference was statistically significant (P < .05). After nursing, the sleep quality, increased arousal, unstable sleep, and night terrors of the 2 groups of elderly patients with cervicitis were significantly improved, and the negative emotion score of the observation group was significantly lower than that of the control group. Statistics show that this difference is statistically significant (P < .05). The comparison of the quality of life scores of the 2 groups of patients before nursing was not statistically significant (P > .05). After nursing, the mental vitality score, social interaction score, emotional restriction score, and mental status of the observation group were significantly higher than those of the control group. Statistics showed that the difference was statistically significant (P < .05). After nursing, the psychological pressure of the 2 groups of elderly patients with cervicitis was significantly improved, and the observation group fear, anxiety, desire for knowledge, fear of discrimination, despair, and low self-esteem were significantly lower than those of the control group. The difference was statistically significant (P < .05). Predictive nursing can effectively improve the quality of life and sleep of elderly patients with cervicitis, reduce psychological pressure, improve compliance and sleep quality, and benefit the prognosis and clinical treatment of patients. It has a certain reference value for the nursing of elderly patients with cervicitis.

15 Dec 2023·Medicine

Efficacy and safety of fezolinetant, a neurokinin-3 antagonist, in treating vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis

Review

Author: Usman, Muhammad ; Jaffar, Huda ; Anjum, Muhammad Umair ; Bhattarai, Pratik ; Kashif, Talha Bin ; Rahman, Ummi Aiman ; Cheema, Huzaifa Ahmad ; Hasanain, Muhammad ; Rana, Maham

Background:Menopause causes a variety of symptoms such as hot flashes and night sweats. While menopausal hormonal therapy has been used for managing postmenopausal vasomotor symptoms (VMS) for quite a while, it has a considerably poor safety profile.Objective:To review and analyze existing data to evaluate the efficacy of the neurokinin-3 antagonist, fezolinetant, in treating postmenopausal VMS and to assess its safety profile.Methods:A thorough literature search was performed on PubMed, Cochrane Library, and Google Scholar in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020, to find publications on the efficacy of fezolinetant for postmenopausal VMS. Changes in the frequency and severity scores of moderate/severe VMS and changes in the Hot Flash-Related Daily Interference Scale (HFRDIS), Greene Climacteric Scale (GCS), and Menopause-Specific Quality of Life (MENQoL) were the efficacy outcomes. Adverse events, drug-related treatment-emergent adverse effects (TEAEs), drug-related dropouts, hepatotoxicity, endometrial hyperplasia or tumor, and uterine bleeding were all safety outcomes. We used Review Manager 5.4 for pooling risk ratios (RRs) and mean differences (MDs) for dichotomous and continuous outcomes, respectively. A P value of < .05 was considered significant.Results:There was a significant reduction in mean daily VMS frequency at weeks 4 and 12 (MD, −2.36; 95% confidence interval [CI], −2.85 to −1.87; P < .00001, for week 12) and also a significant decrease in VMS severity scores in the treatment group. Furthermore, improvements in MENQoL, HFRDIS, and GCS scores were observed. There was no significant difference in adverse events while drug-related TEAEs (RR, 1.21; 95% CI, 0.90–1.63; P = .21) showed a slight increase with fezolinetant. Drug-related dropouts were again similar across the 2 groups. Uterine bleeding had a lower incidence while endometrial events and hepatotoxicity showed a statistically insignificant, increasing trend in the fezolinetant group.Discussion and implications:Fezolinetant can be a treatment option for postmenopausal VMS but warns of a risk increase in endometrial hyperplasia or tumors. The heterogeneity in the data being analyzed, short follow-up period, and small sample size in most of the included randomized controlled trials were the greatest limitations, which must be considered in further research and safety profile exploration.

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