Clinical trials: Fibroids, Uterine
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
- Trial name
- PEARLIII (NCT01156857)
- Testing
- PGL4001, progestin
- Where
- 23 sites in Austria, Belgium and 2 more
- Volunteers
- 209 people
- Sponsor
- PregLem SA
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after…
- Trial name
- NCT01252069
- Testing
- PGL4001, progestin, drug free period
- Where
- 18 sites in Austria, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- PregLem SA
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a…
- Trial name
- PEARLext2 (NCT01642472)
- Testing
- Ulipristal Acetate - open label
- Where
- 16 sites in Austria, Belgium and 2 more
- Volunteers
- 64 people
- Sponsor
- PregLem SA
Uterine Fibroids
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
- Trial name
- NCT01588899
- Testing
- MR-HIFU uterine fibroid treatment
- Where
- 2 sites in China
- Volunteers
- 107 people
- Sponsor
- Philips Healthcare
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-EU (NCT01226290)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 51 people
- Sponsor
- Gynesonics
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study - Large Fibroids
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-L (NCT01539187)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 6 people
- Sponsor
- Gynesonics
Menorrhagia, Leiomyoma
Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system.
- Conditions
- Menorrhagia, Leiomyoma, Uterine Fibroids, Uterine Fibroma
- Trial name
- NCT01998854
- Testing
- VizAblate System
- Where
- 2 sites in France
- Volunteers
- 4 people
- Sponsor
- Gynesonics
Uterine Fibroids
A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.
- Trial name
- PREMYA (NCT01635452)
- Where
- 75 sites in Austria, France and 8 more
- Volunteers
- 1,500 people
- Sponsor
- PregLem SA
Uterine Fibroids
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
- Trial name
- NCT01451424
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics Inc.
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
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, Anemia
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment.
- Trial name
- NCT00702702
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 30 sites in United States
- Volunteers
- 56 people
- Sponsor
- Repros Therapeutics Inc.
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.
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.
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
- Trial name
- NCT00785356
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 7 sites in Mexico
- Volunteers
- 8 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® 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
- NCT00853567
- Testing
- Proellex
- Where
- 17 sites in United States
- Volunteers
- 71 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
Safety and efficacy study of 25 and 50 mg doses of Proellex
- Trial name
- NCT01069120
- Testing
- Proellex
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- 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 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.
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.