View clinical trials related to Uterine Fibroids.
Filter by:The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.
This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years.
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention has been paid to the study of minimally invasive methods for treatment. Microwave ablation of myomas and endometrium has been shown to have good effect and acceptability has been high. This study aims to compare the effectiveness, feasibility and acceptability of percutaneous or per vaginal microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study. Primary outcome 1. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic Power calculation To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in microwave ablation and 50%[11] in the embolization group with a standard deviation of 25% with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to randomize 32 women. In order to compensate for loss to follow-up or drop out a total of 36 women will be randomized. Patients and investigators will not be blinded. The MRI will be performed and evaluated by a blinded radiologist. After having signed informed consent but before randomization patients will undergo MRI of the uterine fibroids. Patients with a single fibroid measuring more than mean diameter 8cm will be excluded from further participation in the study. All women included in the study after MRI examination will fill in a PBAC evaluation[7] during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month prior to treatment. Microwave ablation will be performed percutaneously or vaginally using a Covidien Emprint microwave ablation system. Embolization will be performed in conscious women with an epidural catheter for pain relief. At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the treatment to a friend. A new MRI scan will be performed 6 months post treatment (+/-15 days).
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire. Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.