endometriosis in reproductive-age MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Mifepristone 5 mg
Product Code: Mifepristone 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: MIFEPRISTONE
CAS Number: 84371-65-3
Current Sponsor code: NA
Concentration unit: mg mil
Sponsors
Litaphar Laboratorios S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Premenopausal female, from 18 years of age inclusive, at the time of signing consent [2] Patients with Endometriosis Associated Pelvic Pain (EAPP: i.e. any type of pelvic pain associated with endometriosis: non-menstrual pelvic pain, dysmenorrhea, dyschezia and dyspareunia) and with history of EAPP for at least the past 6 months prior to the initial screening visit [3] Endometriosis diagnosed by laparoscopy and/or surgery in the past 10 years or less or diagnosed by MRI or transvaginal ultrasound in the past 5 years [4] Patients with a history of regular menstrual cycles (21-35 days) while not being on any pharmacological treatment that could alter the menstrual cycle (e.g. oral contraceptive pills) [5] Patients who agree to use only ibuprofen 400 mg as rescue medication up to a total daily dose of not more than 2400 mg [6] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent [7] Patient agrees to use double barrier contraception birth control methods (e.g. condom with spermicide) during the entire length of participation in the study. Patient is not required to use double barrier contraception methods if: - Sexual partner(s) is (are) vasectomized, at least 6 months prior to screening - Patient has had a bilateral tubal occlusion (including ligation and blockage methods such as Essure®), at least 3 months prior to screening - Patient is not sexually active with men; periodic sexual relationship(s) with men requires the use of dual non-hormonal contraception as noted above. 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [1] History of hypersensitivity or intolerance to the active substance or any of the excipients of the study medication [2] Subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the study or is less than 6 months postpartum, post-abortion, or post-lactation at the time of entry into the screening period [3] Previous use of hormonal agents before the Screening visit: =24 weeks for GnRH agonists; =12 weeks for depot progestogens and danazol: =6 weeks for oral contraceptives [4] Use of intrauterine device [5] Patients with history of any cancer (including breast cancer) [6] Patients with histological diagnosis of endometrial hyperplasia with or without atypia at screening (note: the combination of endometrial thickness 180 mmHg or > 95 mmHg, respectively [16] Subject with hereditary porphyria [17] Abnormal laboratory findings considered by the investigator as clinically significant [18] Positive results for HBs-Ag, anti-HCV and HIV-1/HIV-2-antibodies [19] Use of drugs that could be expected to affect the release of sex hormones (e.g., antipsychotics); hypericum and CYP3A4 inductors (carbamazepine, phenobarbital, phenytoin, primidone, rifampicin) or inhibitors (such as cyclosporine, macrolide antibiotics, nefazodone, azolic antifungal agents and HIV protease inhibitors) [20] Intake of any analgesics other than ibuprofen: both opioids and non-steroidal anti-inflammatory drugs as well as paracetamol or metamizole during the screening period [21] History of drug or alcohol abuse within 6 months prior to screening [22] Participation in another trial within 3 months from the screening visit date; [23] Previous enrolment in this study or randomisation in study EudraCT 2018-002367-26/Lita-003 [24] Any condition that, in the judgment of the investigator, may interfere with adherence to study procedures or study assessments [25] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study [26] Unreliability or lack of cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of safety of 5 mg of mifepristone for the treatment of endometriosis in premenopausal women during two treatment cycles of 24 weeks each based on the incidence of endometrial abnormalities, defined as cancer or endometrial hyperplasia, as measured by endometrial biopsy.;Secondary Objective: The secondary objectives of the present trial are the assessment of the following safety outcomes after treatment with Mifepristone 5 mg over two 24-week treatment cycles: • change in endometrial thickness as measured by transvaginal ultrasound • safety of mifepristone for the treatment of endometriosis in terms of the incidence of Adverse Events and Serious Adverse Events • vaginal bleeding during treatment with mifepristone. ;Primary end point(s): Histological appearance of the endometrium at Week 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle and Follow-up visit as well as optional at Week 12 of the 1st treatment cycle and at Week 0 of the 2nd treatment cycle. The overall outcome analysed will be binary: • Cancer or endometrial hyperplasia • All other assessments, including PAECs ;Timepoint(s) of evaluation of this end point: at Week 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes from baseline in endometrial thickness at Weeks 12 and 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle. • Evaluation of vaginal bleeding throughout the trial ;Timepoint(s) of evaluation of this end point: • Changes from baseline in endometrial thickness at Weeks 12 and 24 of the 1st treatment cycle and Week 24 of the 2nd treatment cycle. • Evaluation of vaginal bleeding throughout the trial | — |
Countries
Hungary, Poland, Ukraine
Contacts
Public ContactProject Manager
Litaphar Laboratorios S.L.
Outcome results
None listed