Endometrial pain
Conditions
Interventions
Product Code: SH T 00397H
Pharmaceutical Form: Tablet
Current Sponsor code: ZK811752
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent. 2. Women between 18 and 45 years of age, inclusive 3. Pain associated with histologically proven endometriosis, as determined by diagnostic laparoscopy or laparotomy within 24 months prior to start of treatment (Baseline, Visit 2) but no later than 6 weeks prior to Screening (Visit 1) 4. Threshold for pelvic pain score: minimum 40 mm on VAS at Screening (Visit 1) and at Baseline (Visit 2) 5. Women with cyclic menstrual bleeding 6. Normal cervical smear within the last 6 months according to Papanicolaou (PAP) classification 7. Good general health (except for findings related to endometriosis, with or without infertility) 8. Willingness to use a barrier contraceptive method (unless bilateral tubal ligation has been performed previously), but no hormonal contraception 9. Willingness to use only up to 3 Ibuprofen 400 mg tablets as pain killer for endometriosis-related pelvic pain 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or lactation before start of treatment (SOT) 2. Amenorrhea of more than 1 cycle within 3 months prior to study start 3. Bearing of an intra-uterine device (IUD, either hormonal or non-hormonal) 4. Signs and/or symptoms of therapy-resistent endometriosis despite various attempts of drug treatment or extensive surgical therapy 5. Need for primary surgical treatment of endometriosis according to the investigator 6. Previous / current use of hormonal agents including -GnRH agonists and depot contraceptives within 6 cycles prior to Screening (Visit 1) -Progestins and danazol within 3 cycles prior to Screening (Visit 1) -Hormonal contraception within 1 cycle prior to Screening (Visit 1) -Phytoestrogen intake must be stopped at Screening (Visit 1) 7. Significant, incompletely-healed preexisting illnesses for which it can be assumed that absorption, distribution, metabolism, elimination, and effects of the investigational product will not be normal (e.g. gastrointestinal, autoimmune, signs for immune deficiency) 8. Actual or history of cardiovascular disorders 9. Family history of long QT-syndrome 10. Clinically relevant ECG findings, in particular prolonged QT interval (QT interval after Bazett’s correction for heart rate >440 msec), bradycardia < 50 bpm and signs of ventricular hypertrophy at screening (Visit 1) 11. Abnormal baseline laboratory values that are beyond inclusion range, as defined by the Sponsor or that are considered clinically significant by the investigator 12. Conditions or medications that are prone to electrolyte changes (e.g. hypokalemia, hypomagnesemia) 13. Treatment with drugs that are potent inductors or inhibitors of CYP3A4 or drugs that are predominantly metabolised via CYP3A4, 2C9 or 2C19 and the increased plasma levels or prolonged action of which may lead to potentially serious side effects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety, tolerability, and efficacy of ZK 811752 compared to placebo given orally three times daily over 12 weeks in the treatment of endometriosis ;Secondary Objective: Biberoglu and Behrman severity profile for symptoms and findings and non-medical parameters (global assessment of efficacy) will be assessed. Safety aspects (AEs, ECG monitoring, bleeding pattern, gynecological safety, laboratory evaluations) will be monitored throughout the study.;Primary end point(s): The primary efficacy variable is the individual absolute change of endometriosis-associated pelvic pain as determined by the composite parameter of change of VAS (in mm) and change of intake of rescue medication (cumulative) between Baseline and End of Treatment. | — |
Countries
Czech Republic, Denmark, Finland, Spain, Sweden
Outcome results
None listed