Clinical trials: Uterine Leiomyomas
Uterine Fibroid
Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy
Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without treatment of co-existing pathology e.g.
- Trial name
- NCT03450421
- Testing
- Actamax™Adhesion Barrier
- Volunteers
- 152 people
- Sponsor
- Actamax Surgical Materials LLC
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
Uterine Fibroids
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.
- Trial name
- NCT01739621
- Testing
- Proellex 12 mg, Proellex 24 mg
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics Inc.
Heavy Menstrual Bleeding, Uterine Fibroids
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids.
- Trial name
- NCT06671548
- Testing
- Relugolix
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Symptomatic Uterine Fibroids
Laparoscopic Cryoablation of Uterine Fibroids
The goal of this study is to evaluate the safety \& efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
- Trial name
- UFREEZE-01 (NCT01735812)
- Testing
- IceSense3 system
- Where
- Israel
- Sponsor
- IceCure Medical Ltd.
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
Uterine Fibroids
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).
- Trial name
- NCT04567589
- Where
- United States
- Sponsor
- Allergan
Uterine Fibroids
Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology.
- Trial name
- NCT00874302
- Testing
- Proellex
- Where
- 20 sites in United States, Brazil
- Sponsor
- Repros Therapeutics Inc.
Uterine Myoma
A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers
- Trial name
- NCT03156127
- Testing
- BR-UPS 5 mg tablet, Inisia 5 mg tablet
- Where
- South Korea
- Volunteers
- healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
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, 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 2 (NCT03070951)
- Testing
- OBE2109, Add-back
- Where
- 96 sites in United States, Bulgaria and 7 more
- Volunteers
- 511 people
- Sponsor
- ObsEva SA
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
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.
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.
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.
Uterine Fibroids
A Study to Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.
- Trial name
- ASTEROID 5 (NCT03240523)
- Testing
- Vilaprisan (BAY1002670)
- Where
- 139 sites in Australia, Austria and 21 more
- Volunteers
- 766 people
- Sponsor
- Bayer
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
Leiomyoma, Menorrhagia
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156195
- Testing
- Asoprisnil
- Volunteers
- 523 people
- Sponsor
- Abbott