Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosis

Phase 1

• Conditions: endometriosis in reproductive-age; MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System 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: EUCTR2018-002367-26-HU
• Lead Sponsor: itaphar Laboratorios

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-06
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 490

Inclusion Criteria

[1] Premenopausal female, between 18 and 45 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) as measured by Visual Analogue Scale (VAS) = 40 mm at least once in the previous 4 weeks from baseline visit
[3] patients with a history of EAPP for at least the past 6 months prior to the initial screening visit
[4] 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
[5] 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)
[6] Patients who agree to use only ibuprofen 400 mg as rescue medication up to a total daily dose of not more than 2400 mg
[7] 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
[8] 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 490
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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] Patients with history of any cancer (including breast cancer) and/or histological diagnosis of endometrial atypical hyperplasia at baseline (note: the combination of endometrial thickness <5 mm determined by transvaginal ultrasound and insufficient material for histological evaluation from the endometrial biopsy will be regarded as atrophic endometrium)
[5] Other clinically significant gynaecological condition causing abnormal uterine bleeding already known or identified on Screening such as severe adenomyosis or symptomatic uterine fibroids requiring treatment
[6] Subject has current or history of abnormal genital bleeding
[7] Presence of ovarian cyst of unknown etiology
[8] Cervical smear with pathological findings: class III or higher according to Papanicolaou, class IIp or higher according to the Munich III nomenclature or ASC-US or higher according to the Bethesda system
[9] Surgical treatment of endometriosis within 3 months prior to the screening visit
[10] Presence of chronic pain other than pain due to endometriosis
[11] Hepatic insufficiency
[12] History of, or complications of, thrombosis, embolism, or serious cardiac, respiratory (severe asthma not adequately controlled by treatment), renal, hematologic, endocrine diseases
[13] Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure > 180 mmHg or > 95 mmHg, respectively
[14] Subject with hereditary porphyria
[15] Abnormal laboratory findings considered by the investigator as clinically significant
[16] Positive results for HBs-Ag, anti-HCV and HIV-1/HIV-2-antibodies
[17] 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)
[18] 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
[19] History of drug or alcohol abuse within 6 months prior to screening
[20] Participation in another trial within 3 months from the screening visit date;
[21] Previous enrolment in this study
[22] Any condition that, in the judgment of the investigator, may interfere with adherence to study procedures or study assessments
[23] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study

Study & Design

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