A randomized, double-blind, three-arm, parallel-group, multicentre superiority study assessing the efficacy and safety of mifepristone (2.5 mg and 5 mg) vs. placebo for the treatment of endometriosis in reproductive-age women for 24 weeks PLUS an efficacy and safety follow-up in patients treated with 2.5 mg and 5 mg of mifepristone

itaphar Laboratorios0 sites490 target enrollmentFebruary 6, 2019

Conditionsendometriosis 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]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: endometriosis in reproductive-age
Sponsor: itaphar Laboratorios
Enrollment: 490
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 6, 2019

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

itaphar Laboratorios

Eligibility Criteria

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

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