Clinical trials: Fibroid
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in…
- Trial name
- NCT01441635
- Testing
- Elagolix, Estradiol/Norethindrone acetate (E2/NETA), Estradiol
- Volunteers
- 271 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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, 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 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, 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 Fibroid, Endometriosis
Bone Mineral Density in Women With Uterine Fibroids or Endometriosis
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.
- Trial name
- NCT03744507
- Where
- 63 sites in United States, Australia and 5 more
- Volunteers
- 660 people
- Sponsor
- Myovant Sciences GmbH
Uterine Fibroids
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Patients in Canada.
- Trial name
- NCT04567095
- Where
- United States
- 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
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 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
Uterine Fibroids
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
The primary objective of this study is 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 are to…
- Trial name
- ASTEROID 7 (NCT03699176)
- Testing
- Vilaprisan (BAY1002670)
- Where
- 8 sites in Japan
- Sponsor
- Bayer
Uterine Fibroids, Endometriosis
Pharmacokinetics and Safety of Vilaprisan in Renal Impairment
The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.
- Trial name
- NCT03411980
- Testing
- Vilaprisan (BAY1002670)
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Uterine Fibroids, Adhesions
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
- Trial name
- OPEN (NCT02844920)
- Testing
- Intrauterine ultrasound guided radio-frequency ablation
- Where
- 6 sites in Germany, Netherlands and 2 more
- Volunteers
- 37 people
- Sponsor
- Gynesonics
Uterine Fibroid, Myoma
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
- Conditions
- Uterine Fibroid, Myoma, Leiomyoma
- Trial name
- NCT03427671
- Testing
- Occlusin 500 Microspheres
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- IMBiotechnologies Ltd.
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
- Trial name
- PEARLIV (NCT01629563)
- Testing
- PGL4001 5 mg, PGL4001 10 mg
- Where
- 49 sites in Belgium, Czechia and 9 more
- Volunteers
- 451 people
- Sponsor
- PregLem SA
Uterine Fibroid
A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy
To investigate the efficacy and adverse effects of mifepristone tablets in widely used conditions, to evaluate the relationship between interests and risks used in general or special populations, to further observe the safety and…
- Trial name
- NCT03210324
- Testing
- Mifepristone tablets
- Where
- 26 sites in China
- Volunteers
- 434 people
- Sponsor
- China Resources Zizhu Pharmaceutical Co., Ltd.
Fibroids, Uterine, Leiomyoma
Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)
This pilot study evaluates the safety and tolerability of a single injection of collagenase enzyme directly into a uterine fibroid in subjects already selected for hysterectomy or myomectomy.
- Trial name
- NCT02889848
- Testing
- Saline, EN3835
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Advance Biofactures Corporation
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.
Uterine Fibroids
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to…
- Trial name
- NCT02323646
- Testing
- Telapristone Acetate
- Where
- 8 sites in United States
- Volunteers
- 42 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to…
- Trial name
- NCT02301897
- Testing
- Telapristone Acetate
- Where
- 16 sites in United States
- Volunteers
- 43 people
- Sponsor
- Repros Therapeutics Inc.