Phase III, open-label, multi-centre study to investigate the movement, effect and safety of Zoreline 3.6 mg goserelin implant (Novalon) injected under skin, in women with confirmed endometriosis

Phase 1

• Conditions: Endometriosis; MedDRA version: 19.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-000798-59-HU
• Lead Sponsor: ovalon S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-23
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 142

Inclusion Criteria

1.Premenopausal women aged between 18 and 45 years inclusive;
2.Clinical diagnosis of endometriosis within the last 5 years and indicated for hormonal suppression therapy. Clinical diagnosis should be based on clinical symptoms of endometriosis (such as chronic pelvic pain, dyspareunia, cyclic intestinal pain [bloating/diarrhoea/constipation], uterine cramping in young females, severe dysmenorrhea, dyspareunia, ovulation pain, cyclical/menstrual symptoms with or without abnormal bleeding, infertility, chronic fatigue) confirmed by laparoscopy with or without histology and/or transvaginal/rectal ultrasound (bladder, ovarian or rectum locations) and/or enema studies (for deeply infiltrating endometriosis);
3.Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vital signs;
4.Willing to provide informed consent in writing;
5.Willing to use non-hormonal anti-conception method (male/female condom/copper intrauterine device [IUD]) from Screening (Visit 1; Day -28 to Day -4) till the end of treatment period (Visit 14; Day 85±2 days);
6.Willing and able to attend the scheduled study visits and to comply with the study procedures;
7.Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous or current hormonal treatment for endometriosis, including GnRH receptor agonists, GnRH receptor antagonists, within 6 months prior to the screening visit;
2.Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) or aspartate transaminase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =2 x upper limit of normal (ULN);
3.Moderate (stage 3B) or severe (stage 4 and 5) chronic kidney disease with an estimated glomerular filtration rate (eGFR), using the modification of diet in renal disease (MDRD) equation, <45 mL/min/1,73 m2;
4.Use of contraceptive treatments that interfere with oestradiol plasma level 1 week (or 5 half lives; whichever is longest) before IMP administration;
5.Has endometriosis surgery scheduled for between the Screening and Enrolment visit. (Endometriosis surgery allowed following Visit 14 [Day 85±2 days]);
6.Implanted progestin treatment should be released at least 1 month before study enrolment;
7.Has received an investigational drug within the last 28 days before the Screening visit (Visit 1) or longer if considered to possibly influencing the outcome of this study;
8.Has an unstable medical condition or chronic disease such as but not limited to neurological hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease;
9.History or presence of any malignancy other than treated squamous cell/basal cell carcinoma of the skin within the last 5 years;
10.Evidence (including clinically significant abnormal bilirubin and/or albumin values) or history of chronic hepatic disease;
11.Have a repeatable prolongation of the QTc interval at screening (mean QTcB =450 ms); or personal or family history of long QT syndrome or significant risk factors of prolonged QT interval arrhythmias. (as determined by the investigator);
12.Patient for which a possible loss in bone mass which in the judgment of the investigator would affect the patient's health;
13.History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the IMP;
14.Other abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the study;
15.Pregnancy (or willingness to become pregnant during the study) or breast-feeding during study period;
16.Has an intellectual incapacity or inability to comprehend, precluding adequate understanding or co-operation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified