A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas.

Phase 3

Conditions: fibroids
uterine myomas
10038595

Registration Number: NL-OMON33654

Lead Sponsor: Preglem S.A

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

Written informed consent prior to any study related procedures.
Pre-menopausal woman between 18 and 50 years inclusive.
PBAC score >100 during day 1 to day 8 of menstruation preceding the baseline visit.
Myomatous uterus <= 16 weeks.
At least one uterine myoma of >= 3 cm diameter in size and no myoma larger than 10 cm diameter in size diagnosed by ultrasound.
Must be eligible for one of these surgical procedures: i.e. hysterectomy, myomectomy, uterine artery embolization or endometrial ablation within 13 weeks and up to 14 weeks from baseline study visit.
Clinical breast examination without significant findings at the screening visit.
No clinically significant findings at PAP smear, performed within the past 12 months or at the screening visit.
If of childbearing potential, the subject must be practicing a non-hormonal method of contraception
Non childbearing potential, tubal ligation sterilisation at least two months before study start.
BMI >= 18 and <= 40.

Exclusion Criteria

Uterus surgery (except caesarean section or cervical conisation), endometrium ablation or uterine artery embolization.
History of or current uterine, cervical, ovarian or breast cancer.
Has a history of atypical hyperplasia or current endometrium hyperplasia (atypical or non-atypical) or adenocarcinoma or similar lesions in the screening biopsy or in a biopsy performed within the past 6 months.
Condition requiring immediate blood transfusion or a level of Hb <= 6 g/dL.
Known hemoglobinopathy (i.e. Sickel Cell anaemia and Thalassämia).
Known severe coagulation disorder.
Large uterine polyp (> 2cm).
One or more ovarian cysts >= 4cm in diameter diagnosed by US.
History of or current treatment for myoma with a SPRM or a GnRH-agonist.
Taking treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive: within the month before the screening visit. Or Acetylsalicylic acid and/or mefenamic acid, anticoagulants such as cumarins and /or antifibrinolytic drugs such as tranexamic: within one week before the screening visit, or Systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months before the screening visit, respectively.
Likely to require treatment during the study with drugs that are not permitted by the study protocol: progestins (systemic or progestin releasing intra-uterine system), oral contraceptives, systemic glucocorticoids (oral and injectable), acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrynolytic drugs such as tranexamic acid
History of or known current osteoporosis.
Abnormal hepatic function at study entry (defined as AST, ALT, γGT, alkaline phosphatase or total bilirubin above 2 ULN).
Positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Current (within twelve months) problem with alcohol or drug abuse.
Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
The subject has abnormal baseline findings, any other medical condition(s) or psychiatric condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject*s safety or interfere with study evaluations. This does include the use of agents known to induce or inhibit the hepatic cytochrome CYP3A4.
Allergy to GnRH agonist, SPRMs or progestins or any of the ingredients of the study drug tablet (see list of ingredients in the investigator*s brochure),
Currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.