PGL4001 Versus Placebo in Uterine Myomas (PEARLI)

PregLem

Status and phase: Completed; Phase 3

Conditions: Uterine Myomas

Treatments: Drug: PGL4001 (ulipristal) and iron; Drug: PGL4001 matching placebo and iron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00755755

PGL07-021

Details and patient eligibility

About

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.

Enrollment: 241 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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241 participants in 3 patient groups, including a placebo group

A (PGL4001 5mg)

Experimental group

Description:

PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Treatment:

Drug: PGL4001 (ulipristal) and iron

Drug: PGL4001 (ulipristal) and iron

B (PGL4001 10mg)

Experimental group

Description:

PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Treatment:

Drug: PGL4001 (ulipristal) and iron

Drug: PGL4001 (ulipristal) and iron

C (placebo)

Placebo Comparator group

Description:

PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+

Treatment:

Drug: PGL4001 matching placebo and iron