Advertisement

Topics

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

2014-08-27 03:12:25 | BioPortfolio

Summary

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.

Description

PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Uterine Fibroids

Intervention

PGL4001, placebo, PGL4001, progestin

Location

Cliniques Universitaires Saint-Luc
Bruxelles
Belgium
1200

Status

Recruiting

Source

PregLem SA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:25-0400

Clinical Trials [464 Associated Clinical Trials listed on BioPortfolio]

PGL4001 Versus Placebo in Uterine Myomas

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operat...

PGL4001 Versus GnRH-agonist in Uterine Myomas

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterin...

A Placebo-Controlled, Phase 3 Study of TAK-385 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

The purpose of this study is to evaluate the efficacy of TAK-385 40 mg administered orally once daily for 12 weeks, compared with placebo in participants having pain symptoms associated wi...

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 second...

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 th...

PubMed Articles [1430 Associated PubMed Articles listed on BioPortfolio]

Uterine Fibroids and the Risk of Cardiovascular Disease in the Coronary Artery Risk Development in Young Adult Women's Study.

Uterine fibroids, the most common reproductive tract tumor in women, have been associated with hypertension and atherosclerotic cardiovascular disease (CVD). Prior studies of fibroids and CVD have exa...

Misdiagnosis of leiomyosarcoma after radiofrequency ablation of uterine fibroids.

Minimally invasive therapies to treat symptoms of uterine fibroids can be effective alternatives to major surgery. Such modalities include pharmacologic agents, uterine artery embolization (UAE), MR g...

Burden, Prevalence, and Treatment of Uterine Fibroids: A Survey of US Women.

Most women will experience uterine fibroids by the age of 50, yet few data exist describing the overall patient experience with fibroids. The objective of this population-based survey was to character...

Reintervention Rates After Myomectomy, Endometrial Ablation, and Uterine Artery Embolization for Patients with Uterine Fibroids.

Women with uterine fibroids (UF) may undergo less invasive procedures than hysterectomy, including myomectomy, endometrial ablation (EA), and uterine artery embolization (UAE); however, long-term need...

Changes in sexuality during ulipristal acetate treatment in women with symptomatic uterine fibroids.

To evaluate changes in sexuality in women treated with Ulipristal acetate (UPA) due to symptomatic uterine fibroids.

Medical and Biotech [MESH] Definitions

A synthetic progestin which is useful for the study of progestin distribution and progestin tissue receptors, as it is not bound by transcortin and binds to progesterone receptors with a higher association constant than progesterone.

Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.

Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.

Tumors or cancer of the UTERINE CERVIX.

Pathological processes of the UTERINE CERVIX.

More From BioPortfolio on "PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial