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-DE
- Lead Sponsor
- Bayer Schering Pharma 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/L
2. DUB defined as at least one of the following symptoms within the 90-day run-in
phase:
- Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days
- Frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20
bleeding days overall
- 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. Vascular diseases: Presence or history of venous thromboembolic diseases (deep
vein thrombosis, pulmonary embolism), presence or history of arterial thrombo-
embolic diseases (myocardial infarction, stroke), and any condition which could
increase the risk to suffer from any of the above mentioned disorders, e.g. a
positive family history (event that occurred in a sibling or a parent at an early
age) or a hereditary predisposition
22.
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