Clinical trials: Fibroid
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
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
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 Leiomyomata (Fibroids)
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females
The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.
- Trial name
- NCT00444704
- Testing
- PRA-027
- Where
- Japan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
- Trial name
- NCT00737282
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 25 sites in United States
- Volunteers
- 175 people
- Sponsor
- Repros Therapeutics Inc.
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
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 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
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
Leiomyoma
Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
- Trial name
- NCT03092999
- Testing
- Vilaprisan (BAY1002670)
- Where
- 2 sites in Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
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.
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.
Fertility Issues
Home Examinations Researching and Understanding Submucosal Evaluations
To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to…
- Trial name
- HER-USE (NCT05004870)
- Testing
- Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)
- Where
- United States
- Sponsor
- Turtle Health, Inc.
Uterine Leiomyomas
Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner
This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner.
- Trial name
- NCT01064960
- Testing
- Philips MR-guided HIFU system
- Where
- Norway
- Volunteers
- 7 people
- Sponsor
- Philips Healthcare
Uterine Leiomyomata (Fibroids)
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and…
- Trial name
- NCT00543790
- Testing
- PRA-027
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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.
Fibroid Uterus, Leiomyoma
Study 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
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156156
- Testing
- Asoprisnil
- Volunteers
- 149 people
- Sponsor
- Abbott
Uterine Fibroids, Leiomyoma
A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy
The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.
- Trial name
- NCT00150644
- Testing
- Asoprisnil
- Volunteers
- 33 people
- Sponsor
- Abbott
Uterine Fibroids, Uterine Myomas
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.
- Trial name
- Halt (NCT00874029)
- Testing
- Halt Procedure
- Where
- 11 sites in United States, Guatemala and 1 more
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Acessa Health, Inc.