PGL4001 Versus GnRH-agonist in Uterine Myomas (PEARLII)

PregLem

Status and phase: Completed; Phase 3

Conditions: Uterine Myomas

Treatments: Drug: leuprorelin; Drug: PGL4001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00740831

PGL07-022

Details and patient eligibility

About

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.

Enrollment: 301 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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301 participants in 3 patient groups

A (PGL4001 5 mg)

Experimental group

Description:

Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

Treatment:

Drug: PGL4001

B (PGL4001 10mg)

Experimental group

Description:

Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

Treatment:

Drug: PGL4001

C (GnRH-agonist)

Active Comparator group

Description:

PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)

Treatment:

Drug: leuprorelin