EUCTR2010-018999-25-BE
Active, not recruiting
Phase 1
A Phase III, multicentre, clinical study investigating the efficacy and safety of 3-months open-label treatment with PGL4001, followed by a randomised, double-blind placebo controlled period of 10 days treatment with progestin, in subjects with myomas and heavy uterine bleeding. - PEARL III: PGL4001 Efficacy Assessment in Reduction of symptoms due to uterine Leiomyomata
PregLem S.A.0 sites200 target enrollmentJune 15, 2010
Conditionsterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly asymptomatic affecting approximately 40% of women between 35 and 55 years. When symptomatic, the main symptoms are heavy uterine bleeding, abdominal pressure, abdominal pain, increased urinary frequency and infertility.MedDRA version: 12.1Level: LLTClassification code 10046801Term: Uterine myoma
DrugsPrimolut-Nor® 10mg
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- terine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly asymptomatic affecting approximately 40% of women between 35 and 55 years. When symptomatic, the main symptoms are heavy uterine bleeding, abdominal pressure, abdominal pain, increased urinary frequency and infertility.
- Sponsor
- PregLem S.A.
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible for inclusion into this study, the subjects must fulfil all of the following criteria:
- •1\.Provision of written informed consent prior to any study related procedures.
- •2\.Subject is a pre\-menopausal woman aged between 18 and 48 years inclusive.
- •3\.Subject with a Body Mass Index \=18 and \=40\.
- •4\.Subject with hormonal levels FSH \= 20 mIU/mL at screening.
- •5\.Subject with regular menstrual cycles \=22 and \=35 days.
- •6\.Subject with myomatous uterus size \< 16 weeks.
- •7\.Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
- •8\.Subject complained of strong uterine bleeding (subjective assessment).
- •9\.Subject is eligible for hysterectomy or myomectomy.
Exclusion Criteria
- •To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- •1\.Subject has a history of uterus surgery that would interfere with the study, including endometrial ablation or uterine artery embolization.
- •2\.Subject has a history of or current uterus, cervix, ovarian or breast cancer.
- •3\.Subject has a significant finding on Papanikolaou test (PAP) smear within the past 12 months.
- •4\.Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
- •5\.Subject has a large uterine polyp (\> 2cm).
- •6\.Subject has calcified myomas and/or calcified uterus.
- •7\.Subject has a known severe coagulation disorder.
- •8\.Subject has one or more ovarian cysts \= 4cm diagnosed by ultrasound.
- •9\.Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
Outcomes
Primary Outcomes
Not specified
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