Clinical Research Directory

Assessment of Sexual Well-being in Patients With Gynecologic Cancer and Their Partners: the ONCOSEX Study

Study type and design This is an observational, exploratory, prospective, longitudinal (cohort), multicenter, non-profit study. Its purpose is to observe changes in sexual function over time without modifying standard clinical care pathways. Background and rationale Sexual dysfunctions and the psychological impact of gynecological cancers are often underestimated in clinical practice, despite the World Health Organization recognizing sexual health as a fundamental right. Cultural, personal, and educational barriers frequently hinder an open and systematic discussion of sexual health. Available literature highlights a significant deterioration in sexual quality of life and couple relationships among these patients; however, clear guidance on validated assessment tools and structured sexual counseling pathways is still lacking. Study objectives Primary objective: to evaluate whether and how sexual function questionnaire scores in patients and their partners change over time at different assessment time points. Secondary objective: to identify the proportion of patients and partners who would perceive sexual counseling as useful, as well as the preferred timing for such support. Endpoints Primary endpoint: variation in Female Sexual Function Index (FSFI) scores in female patients and International Index of Erectile Function (IIEF-15) scores in male partners between assessment time points (T0-T1, T1-T2, T0-T2). Secondary endpoint: perceived usefulness of sexual counseling support and preferred timing, based on questionnaire responses. Procedures and assessment timeline Patients are enrolled at the time of diagnosis communication (T0). The same questionnaire is administered again six months after the start of treatment (T1) and twelve months after completion of therapy or surgery (T2). Participation requires written informed consent, and all data are collected in a pseudo-anonymized format. Partners are enrolled and assessed at the same time points. Assessment tools Patients: the validated Female Sexual Function Index (FSFI) questionnaire, plus an additional structured section exploring sexual experience, satisfaction, and difficulties. Partners: the IIEF-15 questionnaire for male partners; for female partners, the same instruments used for patients are administered. Collected variables Sociodemographic and clinical data, lifestyle habits, sleep quality, marital status, parity, ongoing or previous therapies, and FSFI and IIEF-15 questionnaire scores. Sample size A total of 200 patients and 200 corresponding partners are expected to be enrolled. Statistical analysis Data will be analyzed descriptively and longitudinally across the three time points. The primary analysis will use linear mixed-effects models for repeated measures, including random effects for subjects and fixed effects for time and relevant clinical covariates. Predefined subgroup analyses are planned. Statistical significance is set at p \< 0.05.

Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness

This randomized, double-blind, placebo-controlled clinical study is designed to evaluate the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) in improving women's sexual wellness. Sexual wellness is assessed as a multidimensional construct encompassing sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers. Participants will receive either Shatavari root extract or placebo for 12 weeks, with assessments conducted at baseline and follow-up visits.

The Effect of Lemongrass on Aerobic Performance

The goal of this experimental study is to examine the influence of Lemongrass extract on aerobic training parameters following a 6-week training programme in males. A secondary aim will be to explore the influence on sexual wellness. Participants will attend 23 visits to the laboratory involving: * fitness testing (some to exhaustion). * blood sampling (capillary and venous samples). * a supervised 6 week high-intensity interval training (HIIT) programme. * consuming either the lemongrass extract or placebo in the form of tablets, once a day during the 6 week training.

Sexual Well-being of Women Undergoing Mastectomy and Reconstruction

The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys. This data can support preoperative patient counselling and the prevention and care of adverse effects of cancer treatments. Specific subpopulations of mastectomy women showing severe sexual impairment can be outlined; they may benefit from lifestyle changes and intervention strategies (intravaginal use of diazepam, local hyaluronic acid, intravaginal use of spermidine, pelvic floor gymnastic and physiotherapy). Our goal is to improve quality of life of breast cancer patients.