Treatment of prolonged, excessive or frequent bleeding in women without organic pathology who desire oral contraception.
Conditions
Interventions
Product Name: E2-Pill
Product Code: SH T 00658 EA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: estradiol valerate
CAS Nu
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. >/= 18 years of age and able to read and write. If over 40 years of age, must have FSH =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of organic uterine bleeding such as von Willebrand disease, chronic endometritis, adenomyosis, endometriosis, endometrial polyps, endometrial carcinomas, mixed mullerian mesenchymal tumors, leiomyomas, leiosarcomas, or endometrial stromal tumors 2. Signs of hirsutism 3. Atypical hyperplasia 4. History of endometrial ablation, or dilatation and curettage within 2 months of visit 1 5. Clinically significant abnormal TVU results 6. Clinically significant abnormal results of breast examination 7. Positive pregnancy test 8. Pregnancy, lactation, or abortion within 3 months of visit 1 9. Not willing to discontinue the use of nonsteroidal anti-inflammatory drugs during menses throughout the study 10. Use of medication intended for treatment of DUB symptoms (e.g., tranxenamic acid) 11. Hormonal contraception: ? Oral or intravaginal within 30 days of visit 1 ? Intrauterine device (IUD) still in place within 30 days of visit 1 ? Implants/depots still in place within 30 days of visit 1 ? Intramuscular: visit 1 less than 30 days from the last day of the labeled effective period of use 12. Use of steroidal OC agents during the study 13. Prohibited concomitant medication: Concomitant use of medication inhibiting or inducing cytochrome CYP 3A4 is excluded. In particular is excluded the use of additional steroid hormones, anticoagulants (e.g. heparin, Coumadin), antiepileptics (hydantoin derivatives [e.g., phenytoin] or carboxamid derivatives [e.g., carbamazepin, oxcarbamazepin], other antiepileptics [e.g., Felbamate, Topiramate]), hypnotics and sedatives (barbiturate derivatives [e.g., primidone]), tuberculostatics (e.g., rifampicin), oral antimycotics (e.g., griseofulvin, ketoconazol, itraconazol, fluoconazol), virostatic agents (e.g., ritonavir), products containing St. John's Wort, and continuous (exceeding 14 days) systemic use of antibiotics 14. Any concomitant or active disease or condition that compromises the absorption, distribution, metabolism, or excretion of the study drug (such as compromised renal function, gastrectomy, pancreatitis, renal insufficiency, hepatic dysfunction, active cholecystitis, and cholestatic jaundice) 15. Known or suspected premalignant or malignant disease including malignant melanoma (excluding other successfully treated skin cancers) or a history of these conditions 16. Abnormal laboratory values that are considered clinically significant at the discretion of the investigator and which give suspicion of a specific organ or system dysfunction 17. History of myocardial infarction or coronary heart disease requiring treatment 18. History of congestive heart failure 19. Uncontrolled hypertension; sitting systolic blood pressure >/= 140 mmHg or diastolic blood pressure >/= 90 mmHg 20. History of stroke or transient ischemic attacks 21. Thrombophlebitis or thromboembolic disorder, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke, or a history of these conditions or known or suspected genetic component or positive family history of parents or a sibling or a child at an earl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and safety of estradiol valerate (EV) / dienogest (DNG) treatment in patients with dysfunctional uterine bleeding (DUB) as compared to placebo; Secondary Objective: To determine the efficacy of EV/DNG in regard to individual DUB symptoms and menstrual bleeding parameters To determine the efficacy of EV/DNG in regard to quality of life and resource use assessment To evaluate the effect of EV/DNG on hemoglobin and serum ferritin concentrations ; Primary end point(s): The primary efficacy variable is the overall success rate, which is defined by the number of patients with the absence of any DUB symptom and who have met all the relevant criteria for success during the 90-day efficacy assessment phase, as compared to the number of patients having at least one qualifying DUB symptom during the run-in phase. Individual Components of the Primary Efficacy Variable Absence of DUB symptoms is defined as: · No bleeding episodes lasting more than 7 days and · No more than 4 bleeding episodes and · No bleeding episodes with blood loss volume of 80 mL or more In addition, · No more than 1 bleeding episode increase from baseline and · Total number of bleeding days not to exceed 24 days · No increase from baseline in an individual patient’s total number of bleeding days In addition, for patients enrolled with specific symptoms, the following criteria will have to be met: · If patients enrolled with prolonged bleeding, the decrease between the maximum duration during run-in phase and the maximum duration during the efficacy phase should be at least 2 days · If patients enrolled with excessive bleeding: (1) the blood loss volum | — |
Countries
Czech Republic, Finland, Germany, Hungary, Sweden, United Kingdom
Outcome results
None listed