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Genital Diseases, Male clinical trials

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NCT ID: NCT06190899 Not yet recruiting - Prostate Cancer Clinical Trials

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Start date: January 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.

NCT ID: NCT05777031 Recruiting - Clinical trials for Sexual Dysfunctions, Psychological

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

Start date: October 2, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.

NCT ID: NCT04760483 Active, not recruiting - Clinical trials for Prostatic Hyperplasia

Office Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia HYPERPLASIA

Start date: November 20, 2020
Phase: Phase 1
Study type: Interventional

This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. It will assess the impact in quality of life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in men 40 to 85 years of age with benign prostatic hypertrophy (BPH). BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open lead to relaxation or excision of the bladder neck. Such alteration of the bladder neck function or anatomy portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation among others. This study aims to evaluate the use of TPLA in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety profile and outcomes from TPLA therapy The fundamental objective is to determine the feasibility and safety of TPLA in healthy men with LUTS due to BPH, successful performed in the outpatient office-based setting under local anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA; 3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and 6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements

NCT ID: NCT04512287 Recruiting - Clinical trials for Sexual Dysfunction, Physiological

PRP for Treatment of Peyronie's Disease

Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).

NCT ID: NCT04461509 Active, not recruiting - Neoplasms Clinical Trials

High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy

Start date: April 6, 2021
Phase: Phase 2
Study type: Interventional

This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.

NCT ID: NCT04460872 Recruiting - Clinical trials for Spinal Cord Injuries

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Start date: January 31, 2021
Phase: Phase 2
Study type: Interventional

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

NCT ID: NCT03677336 Completed - Infertility Clinical Trials

Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

Start date: May 1, 2019
Phase: Phase 4
Study type: Interventional

Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.

NCT ID: NCT03344757 Active, not recruiting - Prostate Neoplasm Clinical Trials

Health Gatherings - For Your Health After Cancer

Start date: October 5, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).

NCT ID: NCT03240822 Withdrawn - Amputation Clinical Trials

Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma

Start date: January 2017
Phase: Phase 1
Study type: Interventional

This is a 4-year, non-randomized, single center, patient self-controlled, clinical trial (though enrolled subjects will be followed for life as are all transplant patients) for patients seeking allotransplantation of the male external genitalia (MEG), or penile tissue, as a feasible reconstructive strategy for the treatment of devastating and irreversible injuries to the genitalia. In addition to receiving penile allotransplantation and post-operative monitoring and support, enrolled patients will receive an innovative and clinically proven immunomodulatory protocol that combines lymphocyte depletion of the recipient with donor bone marrow cell infusion. Patients will be treated with lymphocyte depleting induction therapy, donor bone marrow cell infusion and tacrolimus. After the first year, maintenance immunosuppression will be modified gradually and cautiously (tapered dose reduction or spaced frequency dosing of tacrolimus) in selected patients based on a critical evaluation of clinical and immunologic outcomes. Outcomes will include but not be limited to functional metrics (sensation, erection, voiding), psychosocial (body integrity, adaptation to transplant) and health related quality of life (HRQOL) measures.

NCT ID: NCT02606123 Terminated - Prostatic Neoplasms Clinical Trials

Safety and Anti-Tumor Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer

Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumor activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in Part II. In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.