Clinical trials: Leiomyoma
Dysmenorrhea (Disorder), Dysmenorrhea Primary
Mechanistic Characterization of Uterine Pain
There are limited treatment options for management of dysmenorrhea, and the physiological processes they affect are not completely understood.
- Conditions
- Dysmenorrhea (Disorder), Dysmenorrhea Primary, Dysmenorrhea Secondary, Endometrial Diseases
- Trial name
- MCUP (NCT04145518)
- Testing
- Naproxen Sodium
- Where
- United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Contraception
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
- Trial name
- SERENE (NCT04756037)
- Testing
- Relugolix Combination Therapy
- Where
- 112 sites in United States, Puerto Rico
- Volunteers
- 1,164 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Fibroids
Uterine Filling Pressure in Hysteroscopy
The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a MyoSure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.
- Trial name
- NCT04550429
- Testing
- MyoSure Hysteroscopic Morcellator Device
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Northwestern University
Leiomyoma
Dexamethasone for Post Uterine Artery Embolization Pain
The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by…
- Trial name
- Dex-Fib (NCT04655144)
- Testing
- Dexamethasone, Saline
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- University of Miami
Fibroid Uterus, Pain, Postoperative
Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy
The purpose of this study is to assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy.
- Trial name
- WINPLEX (NCT06429163)
- Testing
- Troacar site infiltration, Superior hypogastric plexus block
- Where
- Russia
- Volunteers
- 207 people
- Sponsor
- Saint Petersburg State University, Russia
Uterine Fibroid, Arteriovenous Malformations
An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.
- Conditions
- Uterine Fibroid, Arteriovenous Malformations, Hypervascular Tumors, Benign Prostatic Hyperplasia
- Trial name
- RAVI Registry (NCT04272216)
- Testing
- Treatment with HydroPearl via radial access
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Terumo Medical Corporation
Cancer Debulking, Enlarged Uterus
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than…
- Conditions
- Cancer Debulking, Enlarged Uterus, Fibroid Uterus, Adnexal Mass
- Trial name
- NCT05017246
- Testing
- Bupivacaine, Morphine, Lidocaine
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Washington University School of Medicine
Uterine Fibroids
Assess Safety and Efficacy 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
- Trial name
- ASTEROID 6 (NCT03194646)
- Testing
- Vilaprisan (BAY1002670), Standard of care
- Where
- 219 sites in United States, China and 11 more
- Volunteers
- 1,272 people
- Sponsor
- Bayer
Heavy Menstrual Bleeding, Uterine Fibroids
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This randomized multicenter 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…
- Trial name
- NCT03271489
- Testing
- Elagolix, Estradiol /norethindrone acetate (E2/NETA)
- Where
- 157 sites in United States, Puerto Rico
- Volunteers
- 478 people
- Sponsor
- AbbVie
Leiomyoma
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the…
- Trial name
- NCT02777203
- Testing
- EcoSac 400 ECO-T
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Wake Forest University Health Sciences
Leiomyoma
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
- Trial name
- NCT00290251
- Testing
- ulipristal acetate 20 mg, ulipristal acetate 10 mg
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Uterine Leiomyoma, Uterine Fibroids
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients…
- Trial name
- NCT03751124
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 104 sites in United States, Brazil and 6 more
- Volunteers
- 229 people
- Sponsor
- Myovant Sciences GmbH
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding…
- Trial name
- NCT03412890
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 150 sites in United States, Belgium and 7 more
- Volunteers
- 477 people
- Sponsor
- Myovant Sciences GmbH
Leiomyoma, Laparoscopy
Combined Vaginal Misoprostol and Perivascular Vasopressin
Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal.
- Conditions
- Leiomyoma, Laparoscopy, Uterine Myomectomy
- Trial name
- NCT03815344
- Testing
- Standard, Standard-vaginal misoprostol
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Antonios Likourezos
Leiomyoma
Trial of Mifepristone for Fibroids
The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
- Trial name
- NCT00133705
- Testing
- Mifepristone, Inert Capsule
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Fibroids
Misoprostol for Reduction of Blood Loss During Fibroid Surgery
The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.
- Trial name
- NCT02209545
- Testing
- Misoprostol
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Uterine Fibroids
Pharmacokinetics and Hepatic Safety of EGCG
A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
- Trial name
- NCT04177693
- Testing
- Epigallocatechin gallate (EGCG), Clomiphene Citrate, Letrozole
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Yale University
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
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.
- Trial name
- NCT03400943
- Testing
- Vilaprisan (BAY1002670)
- Where
- 103 sites in United States, Bulgaria and 7 more
- Volunteers
- 93 people
- Sponsor
- Bayer
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo The secondary objectives of this study were to…
- Trial name
- NCT03400956
- Testing
- Vilaprisan (BAY1002670)
- Where
- 87 sites in United States, Czechia and 3 more
- Volunteers
- 103 people
- Sponsor
- Bayer
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy…
- Trial name
- NCT03103087
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 127 sites in United States, Belgium and 6 more
- Volunteers
- 382 people
- Sponsor
- Myovant Sciences GmbH