A clinical trial to study the effects and safety of ulipristal in patients for pre-operative treatment of symptomatic uterine myomas
- Registration Number
- CTRI/2009/091/000398
- Lead Sponsor
- PregLem S.A.12 Chemin des Aulx1228 Plan-les-Ouates, Geneva, Switzerland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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