A clinical trial to study the effects and safety of ulipristal in patients for pre-operative treatment of symptomatic uterine myomas

• Register: CTRI
• Last refreshed on: 4 May 2013
• Main ID: CTRI/2009/091/000398
• Date of registration: 24-06-2009
• Primary sponsor: PregLem S.A. 12 Chemin des Aulx 1228 Plan-les-Ouates, Geneva, Switzerland
• Public title: A clinical trial to study the effects and safety of ulipristal in patients for pre-operative treatment of symptomatic uterine myomas
• Scientific title: A Phase III, randomised, parallel group, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus placebo for pre-operative treatment of symptomatic uterine myomas. Acronym: PEARL I
• Date of first enrolment: 31-10-2008
• Target sample size: 0
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=621
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant Blinded

Countries of recruitment

India

Contacts

• Name: Dr. Vijay Venkatraman Janarthanan
• Affiliation: Clinical Research Physician,ICON Clinical Research India,(P) Ltd

• Name: Mr. Abby Abraham
• Affiliation: Clinical Research Physician,ICON Clinical Research India,(P) Ltd

Key inclusion & exclusion criteria

Inclusion criteria: Key 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: Key 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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Pre-menopausal women with symptomatic uterine myoma(s), excessive uterine bleeding and anaemia for whom a surgical procedure is indicated to treat myomas (i.e. hysterectomy, myomectomy, uterine artery embolization or endometrial ablation)

Intervention(s)

Intervention1: PGL4001: 5mg, 10mg OD For Up To 13 weeks
Intervention2: Placebo: OD for up to 13 weeks
Control Intervention1: Fe2+: 80mg, oral, OD for 13 weeks

Primary Outcome(s)

Primary efficacy objective of this study is to demonstrate superior efficacy of PGL4001 versus placebo to reduce excessive uterine bleeding and to reduce total myoma volumeTimepoint: From screening to end of treatment.

Secondary Outcome(s)

Secondary efficacy objectives are to demonstrate superior efficacy of PGL4001 versus placebo in myoma-related symptoms such as anaemia or pain and to assess PGL4001 capacity to decrease uterine and myoma volume.Timepoint: From screening to end of treatment.

Secondary ID(s)

2008-001804-22

NCT00755755

PGL07-021

Source(s) of Monetary Support

PregLem S.A. 12 Chemin des Aulx 1228 Plan-les-Ouates, Geneva, Switzerland

Secondary Sponsor(s)

ICON Clinical Research India Pvt Ltd Sharadha Towers (unit-II) No: 56/4, 2nd Floor, Nandidurg Road, Bangalore-560046 India