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Uterine Fibroids clinical trials

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NCT ID: NCT01817530 Completed - Uterine Fibroids Clinical Trials

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Start date: April 8, 2013
Phase: Phase 2
Study type: Interventional

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 18 to 51 years of age with uterine fibroids.

NCT ID: NCT01750008 Completed - Uterine Fibroids Clinical Trials

Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions

LUSTOR
Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.

NCT ID: NCT01739621 Completed - Uterine Fibroids Clinical Trials

Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200

Start date: September 2012
Phase: Phase 2
Study type: Interventional

To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.

NCT ID: NCT01642472 Completed - Uterine Fibroids Clinical Trials

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

PEARLext2
Start date: July 2012
Phase: Phase 3
Study type: Interventional

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 total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024). This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.

NCT ID: NCT01631903 Completed - Uterine Fibroids Clinical Trials

Extension of Study ZPV-200

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.

NCT ID: NCT01629563 Completed - Uterine Fibroids Clinical Trials

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

PEARLIV
Start date: June 2012
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01588899 Completed - Uterine Fibroids Clinical Trials

China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids

Start date: May 2012
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01563783 Completed - Uterine Fibroids Clinical Trials

Post Market TRUST Study

TRUST
Start date: December 2012
Phase: N/A
Study type: Interventional

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.

NCT ID: NCT01452659 Completed - Uterine Fibroids Clinical Trials

Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

Start date: October 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

NCT ID: NCT01451424 Completed - Uterine Fibroids Clinical Trials

Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids

Start date: February 2012
Phase: Phase 2
Study type: Interventional

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.