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PGL4001 Versus Placebo in Uterine Myomas

NCT00755755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2012-12-13

Study results available
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Summary

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-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Conditions

  • Uterine Myomas

Interventions

DRUG

PGL4001 (ulipristal) and iron

tablets

DRUG

PGL4001 matching placebo and iron

tablets

DRUG

PGL4001 (ulipristal) and iron

Tablets

Sponsors & Collaborators

  • PregLem SA

    lead INDUSTRY

Principal Investigators

  • Dr Elke Bestel · PregLem SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-03-31
Completion
2010-08-31

Countries

  • Czechia
  • Hungary
  • India
  • Romania
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755755 on ClinicalTrials.gov