Clinical trials: Fibromyoma
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months).
- Trial name
- NCT00735553
- Testing
- Proellex
- Where
- 15 sites in United States
- Volunteers
- 77 people
- Sponsor
- Repros Therapeutics Inc.
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
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 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
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
Fibroid, Myoma
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with…
- Conditions
- Fibroid, Myoma, Leiomyoma
- Trial name
- NCT00891657
- Testing
- SprayShield™
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women…
- Trial name
- NCT01817530
- Testing
- Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate
- Volunteers
- 571 people
- Sponsor
- AbbVie
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
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, Uterine Hemorrhage
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for 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
- NCT02147158
- Testing
- Ulipristal acetate (UPA)
- Where
- 63 sites in United States, Canada
- Volunteers
- 432 people
- Sponsor
- Allergan
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
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
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
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
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.
Cholecystitis, Endometriosis
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic…
- Conditions
- Cholecystitis, Endometriosis, Bowel Obstruction, Fibroids
- Trial name
- NCT02812186
- Testing
- Deep to Moderate NMB, Moderate to Deep NMB, Rocuronium
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Stony Brook University
Uterine Fibroids, Heavy Menstrual Bleeding
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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…
- Trial name
- NCT02925494
- Testing
- Estradiol/Norethindrone Acetate, Elagolix
- Where
- 124 sites in United States, Canada and 1 more
- Volunteers
- 433 people
- Sponsor
- AbbVie
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02691494
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 105 sites in United States, Canada
- Volunteers
- 378 people
- Sponsor
- AbbVie
Uterine Fibroids, Abnormal Uterine Bleeding
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow).
- Conditions
- Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain, Adenomyosis
- Trial name
- 3DRCT (NCT02192606)
- Testing
- Storz 3D Laparoscopy System, 2D Laparoscopy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Uterine Fibroids
An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.
- Trial name
- NCT02811159
- Testing
- Telapristone acetate
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Repros Therapeutics Inc.