Phase 3
N=301
PGL4001 Versus GnRH-agonist in Uterine Myomas
Uterine Myomas
Bottom Line
View on ClinicalTrials.gov: NCT00740831 ↗Enrolled (actual)
301
Serious AEs
4.3%
Results posted
Nov 2012
Primary outcome: Primary: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) — 90.3; 97.9; 89.1 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PGL4001 (Drug); leuprorelin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- PregLem SA
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) |
90.3; 97.9; 89.1 | — |
| PRIMARY Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist |
1.897; 1.843; 1.381 | <0.001 sig |
| PRIMARY Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist |
11.3; 9.7; 39.6 | <0.001 sig |
| SECONDARY Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 |
-0.179; -0.220; -0.268 | — |
Summary
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 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 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 or adenocarcinoma.
- 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 a history of or known current osteoporosis.
- 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 (NCT00740831). 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.