Clinical trials: Fibroids
Heavy Menstrual Bleeding, Uterine Fibroid
LIBERTY 1: 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
- NCT03049735
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 110 sites in United States, Brazil and 4 more
- Volunteers
- 388 people
- Sponsor
- Myovant Sciences GmbH
Heavy Menstrual Bleeding, Menorrhagia
Treatment of Heavy Menstrual Bleeding in Women 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…
- Conditions
- Heavy Menstrual Bleeding, Menorrhagia, Uterine Fibroids
- Trial name
- NCT03317795
- Testing
- Levonorgestrel IUS, Tranexamic Acid
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Shannon K. Laughlin-Tommaso
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
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
- NCT02654054
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 96 sites in United States, Canada and 1 more
- Volunteers
- 413 people
- Sponsor
- AbbVie
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
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women.
- Trial name
- NCT03886220
- Testing
- Elagolix
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 82 people
- Sponsor
- AbbVie
Symptomatic Uterine Fibroids and Adenomyosis
Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure
The uterine fibroid embolization (UFE) procedure is a treatment option for abnormal heavy menstrual bleeding and/or bulk symptoms associated with uterine fibroids and adenomyosis.
- Trial name
- NCT02227316
- Testing
- IV Ibuprofen, IV Acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of California, Los Angeles
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, Uterine Leiomyomata
Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States.
- Trial name
- NCT00837161
- Testing
- Philips MR guided HIFU system
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Philips Healthcare
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.
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 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
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
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
Cutaneous Leiomyomas, Hereditary Leiomyomatosis and Renal Cell Cancer
Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin
Cutaneous leiomyomas are benign tumors of smooth muscle origin. They can be very painful, and current treatments for the tumors and for the associated pain do not produce satisfactory results.
- Trial name
- NCT00971620
- Testing
- Botulinum toxin type A
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Cancer Institute (NCI)
Uterine Fibroids
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
- Trial name
- NCT00683917
- Testing
- Proellex 25 mg, Proellex 50 mg, Lupron Depot
- Where
- 4 sites in United States, Mexico
- Volunteers
- 10 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids, Polyps
HOME Study: Hysteroscopic Office Myomectomy Evaluation
The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine…
- Trial name
- HOME (NCT01152112)
- Testing
- Myomectomy
- Where
- 9 sites in United States
- Volunteers
- 74 people
- Sponsor
- Hologic, Inc.
Uterine Fibroids, With Unexplained Infertility
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained…
- Trial name
- NCT00730886
- Testing
- ExAblate 2000, Myomectomy
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- InSightec
Leiomyoma, Uterine Fibroids
Pilot of Letrozole for Uterine Myomas
PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids.
- Trial name
- PLUM (NCT02470741)
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of California, San Francisco
Leiomyoma, Uterine Fibroids
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia
- Trial name
- NCT00628901
- Testing
- Uterine Fibroid Embolization (UFE), Contour SE™ Microspheres, Embosphere® Microspheres
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
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