28 results
To investigate whether it is possible to manipulate perfusion in type 3 fibroids with MR-HIFU.
- To assess the effect of QBW251 on the pharmacokinetics of a monophasic combined oral contraceptive containing 30 µg ethinyl estradiol (EE) and 150 µg levonorgestrel (LVG).- To assess the effect of QBW251 on the pharmacodynamics of a monophasic…
In this randomized study, timing during (day 1-7 of the menstruation cycle WITH vaginal blood loss) or beyond menstruation (in menstruation cycle day 8 and further WITHOUT vaginal blood loss) will be compared regarding differences in patient-…
To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)
- To establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in NGM/EE Schaffhausen tablets compared with the same hormones in NGM/EE Manati tablets.- To assess the safety and tolerability of both…
The purpose of this study is to quantify the amount of menstrual bleeding in participants with menorrhagia and its correlation to the overall impact of health as measured by the Menorrhagia Questionnaire.
The objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.
To measure the impact of the two opposite communication styles (warm, empathic and cold, formal) on the neurophysiological changes (endogenous dopamine release) in the human brain using positron emission tomography (PET) neuroimaging. This is an…
Our primary objective is to study the effectiveness of hysteroscopic resection for niche related uterine bleeding disorders. The procedure will be performed in small niches with a residual myometrium of more than 3mm.Our secondary objective is to…
The purpose of the study is to evaluate the effectiveness and acceptability of the hot fluid balloon endometrial Thermablate ablation system compared with the Bipolar RF Novasure ablation treatment performed in an outpatient setting in eliminating…
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.
To study if a hysteroscopic resection a safe and effective treatment is for intermittend/post menstrual bloodloss or spotting.
This study primarily aims to get insight in the intraoperative nociceptive state of the patient as an index of the amount of pain stimuli comparing the three modes of hysterectomy. Next to this, by measuring pre-, intra- and postoperative stress…
The primary objective of this study is• To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are• To assess the efficacy of vilaprisan in subjects with uterine fibroids…
To establish the safety and effectiveness of the Sonata System in the treatment of symptomatic uterine fibroids.
Is hysteroscopic resection of submucous myomas under procedural sedation with propofol (PSA) in an outpatient setting a cost-effective alternative for hysteroscopic myomectomy performed under general anesthesia in the operation room?
The aim of this research is to test the efficacy and safety of a new microcatheter 2.8F Sequre for treatment of uterine fibroids and/or adenomyosis with a standard embolization technique and to demonstrate the added value of this catheter, namely to…
This study aims to create an indication of the effect size during and after adherence to the low FODMAP diet to calculate a sample size for a future RCT on this subject.
To study if an online brief CBT intervention is effective for anxiety and depression compared to care as usual (CAU) in patients with PCOS
Primary Objective: Comparing installation and operating time between the Truclear HM device and the Resectr HM device for removal of intrauterine large polyps.Secondary Objective(s): Comparing data on peri- and post operative complications (e.g.…