A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding
- Conditions
- Treatment of prolonged, excessive or frequent bleeding in women without organic pathology who desire oral contraception.
- Registration Number
- EUCTR2005-004340-32-HU
- Lead Sponsor
- Schering AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 180
1. >/= 18 years of age and able to read and write. If over 40 years of age, must have FSH < 40 IU/mL
2. DUB defined as at least one of the following symptoms within the 90-day run-in phase:
(i) Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days
(ii) Frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall
(iii) Excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method
3. Willingness to use barrier contraception (e.g., condoms) from screening to study completion
4. Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion
5. Normal or clinically insignificant Pap smear results. A report within the last 6 months of visit 1 is acceptable.
6. Endometrial biopsy during the run-in phase OR a valid endometrial biopsy performed within 6 months of visit 1, without evidence of malignancy or atypical hyperplasia, with an available report. Women with simple hyperplasia can be included in the study, but will undergo an endometrial biopsy at the end of treatment.
7. Signed the Informed consent form (ICF).
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) yes
F.1.3.1 Number of subjects for this age range
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 early age (22. Uncontrolled thyroid disorders
23. Known sickle cell anemia
24. Known, not adequately controlled diabetes mellitus or with vascular involvement
25. Current or history of migraines with focal neurological symptoms
26. Increased frequency or severity of headaches including migraines during previous estrogen therapy
27. History of drug addiction or alcohol abuse (wi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method