Clinical trials: Fibroids
Laparoscopy, Tissue Adhesion, Surgery-Induced
The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)
This study was designed to assess the safety and efficacy of MEDICURTAIN. Patients who underwent total laparoscopic hysterectomy were randomly assigned either into Medicurtain® treatment group or non-treatment control group.
- Conditions
- Laparoscopy, Tissue Adhesion, Surgery-Induced, Leiomyoma of the Uterine Body
- Trial name
- NCT04672421
- Testing
- Medicurtain®
- Where
- South Korea
- Volunteers
- 107 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Uterine Fibroids
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
- Trial name
- NCT00882258
- Testing
- 12.5 mg Proellex, 25 mg Proellex
- Where
- 16 sites in United States
- Volunteers
- 144 people
- Sponsor
- Repros Therapeutics Inc.
Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction
A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets
To assess the relative bioavailability of SHR7280 dry suspension and tablets in healthy subjects. To assess the safety and tolerability of a single dose of SHR7280 dry suspension and tablets.
- Trial name
- NCT05868057
- Testing
- SHR7280 tablets, SHR7280 dry suspension
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Leiomyoma, Uterine Hemorrhage
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
- Trial name
- NCT02147197
- Testing
- Ulipristal acetate (UPA)
- Where
- 28 sites in United States
- Volunteers
- 157 people
- Sponsor
- Allergan
Uterine Fibroids
A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids
The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated with uterine fibroids.
- Trial name
- NCT02655224
- Testing
- Relugolix
- Where
- 11 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Takeda
Uterine Fibroids, Adhesions
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
- Trial name
- OPEN (NCT02844920)
- Testing
- Intrauterine ultrasound guided radio-frequency ablation
- Where
- 6 sites in Germany, Netherlands and 2 more
- Volunteers
- 37 people
- Sponsor
- Gynesonics
Uterine Fibroids
A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.
The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.
- Trial name
- NCT00776074
- Testing
- Leuprorelin (GF), Leuprorelin (GC)
- Volunteers
- 80 people
- Sponsor
- Takeda
Uterine Fibroids (MeSH Heading: Leiomyoma)
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain
- Trial name
- NCT05445167
- Testing
- KLH-2109
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Pregnancy Related, Pregnancy Complications
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care…
- Conditions
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- Trial name
- NCT05739136
- Testing
- Relugolix + Estradiol + Norethindrone Acetate
- Where
- United States
- Volunteers
- 530 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Uterine Fibroids
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
- Trial name
- NCT00958893
- Testing
- 25 mg Proellex
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
- Trial name
- NCT00785356
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 7 sites in Mexico
- Volunteers
- 8 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids (UF)
A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Uterine Fibroids (UF) are benign smooth muscle neoplasms of the uterus that affect women of reproductive age. UFs are one of the leading causes of hospitalizations for gynecological disorders and often lead to hysterectomy.
- Trial name
- Pink Orchid (NCT06058728)
- Where
- United States
- Sponsor
- AbbVie
Leiomyoma, Uterine Fibroids
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST (NCT00768742)
- Testing
- VizAblate Intrauterine Ultrasound-Guided RF Ablation
- Where
- 3 sites in Canada
- Sponsor
- Gynesonics
Myoma;Uterus, Fibroid Uterus
Open Label Immunotherapy of Myoma
Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological…
- Conditions
- Myoma;Uterus, Fibroid Uterus, Leiomyoma, Fibroma
- Trial name
- V3-myoma (NCT03550703)
- Testing
- V3-Myoma
- Where
- Mongolia
- Volunteers
- 30 people
- Sponsor
- Immunitor LLC
Abnormal Uterine Bleeding, Infertility
Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
This study assesses the effectiveness of intrauterine fibroid and polyp removal using the Interlace Medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been…
- Trial name
- NCT01026805
- Testing
- Interlace Medical 1st Generation Hysteroscopic Morcellator
- Volunteers
- 11 people
- Sponsor
- Hologic, Inc.
Uterine Fibroids, Uterine Leiomyomas
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment.
- Trial name
- NCT00295217
- Testing
- ExAblate 2000
- Where
- 4 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- InSightec
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
- Trial name
- PEARLIV (NCT01629563)
- Testing
- PGL4001 5 mg, PGL4001 10 mg
- Where
- 49 sites in Belgium, Czechia and 9 more
- Volunteers
- 451 people
- Sponsor
- PregLem SA
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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…
- Trial name
- PRIMROSE 1 (NCT03070899)
- Testing
- OBE2109, Add-back
- Where
- 116 sites in United States
- Volunteers
- 526 people
- Sponsor
- ObsEva SA
Uterine Leiomyoma
Directed Ablation of Uterine Fibroids Using a Noninvasive Approach
The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis System for treating uterine fibroids in women who are seeking relief from fibroid-related abnormal uterine bleeding but want to avoid…
- Trial name
- DIANA (NCT03219385)
- Testing
- Mirabilis System
- Volunteers
- 180 people
- Sponsor
- Mirabilis Medica, Inc.