Contraception

Researchers are evaluating the use of inhaled Methoxyflurane, a short-acting and self-administered pain reliever, to improve comfort during intrauterine device (IUD) insertion. This trial focuses on women aged 18 to 55 undergoing IUD insertion, aiming to assess whether 3 mL of Methoxyflurane can reduce pain and anxiety and improve patient satisfaction compared to a placebo. The study is a double-blind, randomized controlled trial sponsored by Women's College Hospital. Participants are randomly assigned to receive either a Penthrox inhaler with 3 mL of Methoxyflurane or an identical inhaler containing saline as a placebo. Both groups follow a self-inhalation schedule before speculum insertion and may continue as needed during the procedure. Standard pain management is also provided, including recommendations for over-the-counter pain relievers and the option for a cervical block to help reduce discomfort. During the study, participants will be monitored for pain intensity, anxiety, distress, and satisfaction with pain management at various times before, during, and after the procedure, including up to 24 hours later. Researchers will also track any adverse effects or emergency visits. The main outcome is procedural pain intensity measured 20 minutes after the procedure, with additional assessments of patient and provider satisfaction and the effectiveness of blinding. The trial is expected to run until February 2027.

Researchers are evaluating the performance of two new polyurethane male condoms of different sizes and thicknesses compared to a standard natural rubber latex male condom. The study aims to find out how often each condom type breaks or slips off during vaginal intercourse and to assess how well couples tolerate and accept these condoms. This investigation is sponsored by Reckitt Benckiser Healthcare (UK) Limited and involves healthy monogamous heterosexual couples. Couples will use each of the three condom types during separate assessment periods lasting up to 5 weeks each. During these periods, they will receive a minimum of 5 and a maximum of 7 condoms per type to use during vaginal intercourse. The study uses a randomized, single-masked, three-way crossover design, allowing couples to try each condom type and compare their experience. Participants will be asked to complete questionnaires and scales shortly after each sexual act, reporting any issues such as irritation or discomfort. Data on condom breakage, slippage, and overall acceptability will be collected within 8 hours after intercourse. Partners will also measure erect penis size at the start using a provided kit. Follow-up and adherence are monitored through an electronic web-based platform, with couples expected to have at least one intercourse act per week during each 5-week assessment period.

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

Researchers are evaluating whether self-administered low dose nitrous oxide is safe and effective when used during office-based vasectomy procedures. The trial aims to compare nitrous oxide with a placebo (oxygen) to see if it reduces anxiety and catastrophizing during the procedure. It also looks at its effects on pain, procedure duration, adverse events, and urologists' views on the ease and patient tolerance of the procedure. Participants will be randomly assigned to receive either self-administered nitrous oxide or a placebo oxygen during their vasectomy. The nitrous oxide dose ranges from 20% to 45%, and it is self-adjusted by the participant. The trial is single-blind, meaning participants do not know which treatment they receive. Surveys will be completed before, during, and after the procedure to assess anxiety, pain, and other factors. During the study, participants will complete multiple surveys to measure anxiety using VAS-A and catastrophizing with S-PCS immediately after the procedure. Pain levels will also be assessed during and after the procedure using visual analog scales. Researchers will monitor adverse events for 30 days post-procedure and evaluate urologists' assessments of procedure ease and patient tolerance. The study includes participants aged 18 to 85 and involves careful follow-up to gather all relevant data.

Researchers are evaluating the effects of school-based life skills training, with and without digital literacy training, on adolescent girls in secondary schools in Nigeria. This study aims to understand how these programs influence school performance, retention, socio-emotional and digital skills, health, marriage, fertility, and work outcomes. The study uses a cluster randomized controlled trial design involving girls aged 15 to 20 in three Nigerian states: Kaduna, Katsina, and Kano. Participants are divided into three groups: one group receives a 12-month safe space-based life skills training covering negotiation, communication, sexual and reproductive health, gender-based violence, and climate change; another group receives the same life skills training plus a digital literacy program including word processing, database management, online marketing, online safety, and programming; a third group receives no training during the study. The interventions are delivered within schools, and the trial runs from baseline through midline and endline surveys. Participants will complete surveys before the interventions, six months after intervention completion, and again two years later. These surveys include interviews with the girls and their caregivers to assess outcomes like school graduation, retention, marriage, income activities, digital financial literacy, socio-emotional skills, and many other educational, economic, and health-related measures. The study involves 8,463 girls from 273 schools, with ongoing monitoring to evaluate the impact of these training programs.

Intimate partner violence (IPV) is a significant public health issue linked to serious health and economic consequences including death and poor treatment outcomes. Researchers are studying how alcohol misuse and posttraumatic stress disorder (PTSD) together influence alcohol-related IPV. This study involves couples to better understand these combined effects through controlled laboratory experiments and real-world monitoring over 28 days. Participants in the study will undergo an alcohol administration session aiming for a target breath alcohol concentration of 0.09 to 0.10 g/dL. The study includes couples with a history of physical IPV and where one or both partners may have PTSD or subthreshold PTSD. Researchers will compare findings from the controlled laboratory setting with naturalistic data collected through intensive ambulatory methods, also exploring heart rate variability as a physiological factor. During the study, participants will complete the alcohol administration paradigm and then engage in 28 days of ecological momentary assessment to report experiences of intimate partner aggression. Assessments will include laboratory and naturalistic measures of aggression, as well as psychophysiological monitoring. The study aims to gather detailed data on the interactions between PTSD, alcohol use, and IPV to inform future trauma-informed treatment approaches. The total duration of participation includes the initial lab session plus the 28 days of follow-up monitoring.

Researchers are conducting an observational study to improve understanding of the menstrual cycle and various gynecologic health conditions such as polycystic ovary syndrome (PCOS), infertility, and breast cancer. This study focuses on reproductive health and menstrual patterns in women and aims to gather long-term data to describe these aspects epidemiologically. The study is hosted on the Apple Research app, which participants can use to find, enroll in, and take part in this research. It collects data related to menstrual cycle patterns and the prevalence of gynecologic health conditions over a period of up to 10 years. Participants will engage through the app, providing information about their menstrual cycles and health conditions. The study tracks menstrual cycle patterns and collects epidemiologic data over time, also determining the prevalence of related health issues. This observational approach allows long-term monitoring without administering treatments. The study is expected to continue through November 2029.

This trial investigates the performance and acceptability of three different non-medicated intravaginal rings (IVRs) among sexually active women aged 18 to 49. The study aims to understand how these IVRs, made from different materials, are perceived and tolerated during typical daily activities. The trial is an early phase 1, randomized open-label crossover study focusing on contraceptive usage without medication. Participants will test three types of non-medicated IVRs—two made of silicone and one made of EVA—across two one-day clinic visits. On the first day, women will handle and vaginally insert two rings, performing tasks simulating daily activities; on the second day, they will test the third ring. The study evaluates acceptability using the Intravaginal Ring Acceptability Scale (IVR-AS) over a treatment period of about 13 weeks. Women taking part will undergo screening including medical and pelvic exams to confirm health status and eligibility. During the study, they will be assessed on how acceptable each ring is and how well they perform, with mean acceptability scores measured from enrollment until the end of treatment. Participants must attend all study visits and follow IVR use instructions. The study includes monitoring for safety and adherence, lasting about 13 weeks in total.

Researchers are studying the psychosocial sexual health skills of young adults born in France, including those whose parents were born abroad. The study focuses on understanding the needs of these young people to develop a sexual health education program that supports good sexual health in adulthood. The research aims to provide detailed national data about sexual health competencies among this population, especially considering the vulnerability of young people from immigrant backgrounds. This observational study includes young adults aged 18 to 29 years who were born in France or its territories and are able to read and write French. Participants will be observed over three years, during which interviews will be conducted to explore their psychosocial skills related to sexual health. The study does not include any treatment or intervention but gathers information to propose a health promotion model tailored to the identified needs. Participants will be involved through interviews and assessments over the course of three years from enrollment. The main outcome measured is the development of health education models based on the collected data. The study is sponsored by Centre Hospitalier le Mans and aims to better understand sexual health education needs to support young adults' well-being. The total participation time corresponds to the period of conducting all interviews and analyses within three years.

Researchers are studying permanent sterilization in women requesting tubal sterilization at the time of cesarean delivery. This study compares two techniques for complete salpingectomy: using a hand-held bipolar energy instrument versus traditional suture ligation. The goal is to evaluate short-term clinical outcomes and cost differences, as no preferred technique has yet emerged in current practice. The study involves women who are at least 21 years old, at 24 weeks' gestation or beyond, requesting permanent sterilization during cesarean delivery. Two groups are compared retrospectively: one using a hand-held bipolar energy instrument for salpingectomy, and the other using traditional suture ligation. Data collection covers the surgical procedure and immediate postpartum period. Participants' outcomes include changes in hemoglobin levels one day after surgery, procedure completion rates, blood loss during surgery, adjacent organ damage, need for blood transfusion, operative time, ICU admissions, length of hospital stay, readmissions, reoperation rates, pain scores, surgical site infections, and hospital costs. Monitoring occurs from surgery day up to six weeks postpartum, providing comprehensive clinical and economic data related to each technique.