Sexual Dysfunction

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

This research investigates a new self-administered digital application designed to improve sexual health, quality of life, and psychological distress among survivors of hematopoietic stem cell transplants (HCT). HCT survivors often face long-term sexual dysfunction due to complex biological, psychological, and social factors, which significantly affect their well-being and relationships. The study aims to address these challenges through a multidisciplinary approach delivered via a digital platform. Participants will be randomly assigned to either use the SHIFT digital application or receive enhanced usual care. The SHIFT app includes interactive features like gamification, survivor videos, intimacy exercises, and optional content to engage users over eight weeks. Those in the usual care group will meet with their clinicians and may be referred to specialists if needed but will not have access to the SHIFT app. During the study, participants will complete assessments measuring sexual satisfaction, function, quality of life, anxiety, and depression at various points up to 24 weeks. Researchers will monitor global satisfaction with sex at week 8 as the primary outcome. The study involves medical evaluations and tracks psychological and physical health through questionnaires and scales, aiming to evaluate the impact of the digital intervention on sexual health outcomes and overall well-being in HCT survivors.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled, 4-way cross-over trial to study the effects of pudafensine on vulvodynia, specifically provoked vestibulodynia. The goal is to evaluate the safety and efficacy of a single dose of pudafensine in reducing pain in the vaginal vestibule. This study aims to better understand how pudafensine affects vestibular pain threshold in patients with this condition. Participants receive single doses of pudafensine or placebo in a randomized sequence across four treatment periods. The study includes three different doses of pudafensine and one placebo group, with each participant experiencing all four treatments at different times. The crossover design allows comparison of the drug's impact versus placebo within the same individuals. During the study, participants undergo the Vestibular Pain Threshold Test to measure pain changes in the vaginal vestibule. This evaluation continues through study completion, averaging about one year. Safety and pain response are monitored throughout the trial. Participants are women aged 18 to 65 diagnosed with vulvodynia, and the study excludes those with certain other vulvar or pelvic conditions that could affect pain assessment.

This research evaluates the use of low-intensity shockwave therapy (LI-SWT) as a treatment for men with erectile dysfunction (ED), a condition where it is difficult to achieve or maintain an erection firm enough for sex. The study aims to gather information on which patients benefit from this therapy to better predict outcomes and help guide treatment decisions. The device used has FDA clearance but is not yet approved specifically for ED treatment. Participants will receive six weekly sessions of LI-SWT using the UroGold100™ device, which applies shockwave energy to the penis and perineum. Before treatment, patients complete questionnaires, blood tests, and a non-invasive blood vessel function test with the EndoPAT device. Follow-up visits occur at 3, 6, and 12 months after the initial baseline visit, including additional questionnaires and safety surveys. During the study, researchers will monitor erectile function using the International Index of Erectile Dysfunction-Erectile Function Domain (IIEF-EFD) score, focusing on changes three months after treatment and durability of improvement at six and twelve months. Safety and any adverse effects will be assessed throughout. Total study participation includes baseline assessments, treatment sessions, and follow-up evaluations over one year.

Researchers are evaluating a new treatment called ST-04, a mucoadhesive intraurethral polymer suspension of alprostadil, for adult males with erectile dysfunction (ED). This Phase 2 trial aims to assess the effectiveness of three different dose levels of ST-04, with or without sildenafil, to improve erectile function compared to the participants' baseline. ST-04 is designed to deliver alprostadil directly inside the urethra to promote penile tumescence and erection. Participants will receive up to three escalating doses of ST-04 over a 12-week period, with a maximum of 11 administrations. Dose levels include 500 mcg, 1000 mcg, and 1500 mcg of ST-04, which may be given with or without sildenafil. Each dose is dispersed along the urethra forming a hydrogel that adheres to the lining to achieve its effect. During the study, participants will undergo assessments including the International Index of Erectile Function (IIEF) questionnaire to measure changes in erectile function at baseline and 1 month after each dose level. Additional evaluations include the Erectile Hardness Scale, Sexual Encounter Profile, and the percentage of successful erection onset within 30 minutes of application. Safety will be monitored through the recording of adverse events. The total study duration includes up to 12 weeks of treatment with regular follow-up visits.

Researchers are studying sexual health and vulvovaginal health in premenopausal and perimenopausal women with hormone receptor positive breast cancer who are receiving ovarian suppression. The study aims to find out if starting sexual health counseling and using non-hormonal moisturizers early can prevent or reduce side effects like vaginal dryness and sexual dysfunction. This is compared to the usual care approach where treatment begins only after symptoms appear. Participants will be randomly assigned to one of two groups. One group will receive sexual health counseling and start using non-hormonal moisturizers 3 to 5 times weekly from the beginning of ovarian suppression, along with education about vaginal dilators and a consultation with a pelvic floor physical therapist. The other group will start treatment only after developing symptoms and will receive a list of recommended moisturizers to purchase themselves. Both groups will complete various questionnaires to monitor sexual health and vaginal symptoms. During the study, participants will be monitored through surveys and subjective and objective assessments of vaginal dryness and sexual function. Researchers will track the number of participants who have a score of 4 or higher on the Vaginal Assessment Scale within one year. The study includes regular completion of validated questionnaires and a weekly diary about moisturizer use. The total participation time corresponds with one year of follow-up to evaluate the intervention's impact.

This research aims to evaluate if men can appropriately select and use tadalafil 5 mg tablets as an over-the-counter (OTC) treatment for erectile dysfunction. The study is an open-label actual use trial enrolling about 2,250 men who have symptoms of erectile dysfunction and are interested in OTC treatment. Approximately 1,000 participants are expected to proceed to the use phase based on their responses to a mandatory health survey assessment. Participants will take tadalafil 5 mg tablets orally, one tablet daily, while using a digital health survey tool. The study is conducted remotely via video interaction over a four-month period. It is designed as a single-arm open-label trial, focusing on real-world use of tadalafil as an OTC medication. During the study, researchers will monitor how well participants follow the recommended dosing intervals, their medical conditions, and any adverse events or care-seeking behaviors related to the use of tadalafil. Participants will complete health surveys, record their dosing and symptoms in electronic diaries, and be monitored for safety throughout the 4-month use phase plus a 30-day follow-up period. The main outcomes include adherence to dosing recommendations and appropriate use based on medical assessments.

Researchers are evaluating the effectiveness of acupuncture as part of a combined treatment approach for women experiencing vulvodynia and chronic pelvic pain (CPP), which are common and difficult gynecologic pain conditions. This randomized controlled clinical study aims to compare acupuncture with a waiting list control group to better understand its impact on pain and quality of life. Participants will be randomly assigned to either receive acupuncture treatment or be placed on a waiting list. The acupuncture involves a defined protocol of body and ear acupuncture, using needles stimulated manually and left in place for 20 minutes. Body acupuncture targets specific points on the lower abdomen, back, extremities, and head, while ear acupuncture includes points related to the sympathetic system and genital area. Those in the waiting list group may continue their current standard therapy but cannot start new treatments or acupuncture during the first three months. After this period, they are offered a course of acupuncture treatments over three months. During the study, participants will be assessed at 3 and 6 months for changes in subjective pain perception and health-related quality of life using various questionnaires. Additional measures include subjective improvement and treatment satisfaction evaluated at 3 months. The study monitors outcomes related to pain and quality of life, with total participation lasting at least 6 months. Safety and patient well-being are maintained throughout the trial period.

Researchers are investigating the effects of a high-fat mixed meal containing a whey protein-enriched milk fat globule membrane (MFGM) supplement on heart and brain health markers in middle-to-older-aged, postmenopausal women who are overweight and at moderate risk for cardiovascular disease. This randomized, single-blind, placebo-controlled crossover study aims to understand how this specific nutritional ingredient influences post-meal responses related to cardiovascular and cognitive health. Participants will attend two approximately 8-hour visits. During each visit, they will consume a high-fat meal containing about 75 grams of refined palm oil fat supplemented either with a whey protein-enriched MFGM powdered ingredient or a placebo whey protein-based powdered ingredient without MFGM. The meals are matched for energy and protein content and given in random order with a washout period of at least 21 days between visits. During each visit, researchers will take body measurements and periodically assess heart health through blood pressure and blood vessel stiffness tests. Blood samples will be collected at multiple time points before and after the meal, over a 6-hour period, to measure changes in blood fats, glucose, insulin, and inflammatory markers. Participants will also complete computer-based tests to assess mood and cognitive function. The study will monitor how the supplement affects these heart and brain health markers in the hours following a meal.