Phase 3
N=241
PGL4001 Versus Placebo in Uterine Myomas
Uterine Myomas
Bottom Line
View on ClinicalTrials.gov: NCT00755755 ↗Enrolled (actual)
241
Serious AEs
2.1%
Results posted
Nov 2012
Primary outcome: Primary: Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) — 91.5; 92.5; 18.8 percentage of patients — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PGL4001 (ulipristal) and iron (Drug); PGL4001 matching placebo and iron (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- PregLem SA
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) |
91.5; 92.5; 18.8 | <0.001 sig |
| PRIMARY Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) |
-21.2; -12.3; 3 | 0.002 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have excessive uterine bleeding due to myoma.
- Have a myoma-related anaemia.
- Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.
- Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
- If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
- Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
Exclusion Criteria
- Has a history of or current uterine, cervical, ovarian or breast cancer.
- Has a history of or current endometrium atypical hyperplasia.
- Has a known severe coagulation disorder.
- Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
- Has abnormal hepatic function at study entry.
- Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
- Has a current (within twelve months) problem with alcohol or drug abuse.
- Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Data sourced from ClinicalTrials.gov (NCT00755755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.