Contraception MedDRA version: 19.0 Level: LLT Classification code 10010809 Term: Contraception NOS System Organ Class: 100000004865
Conditions
Interventions
Product Name: BAY 1007626
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: -
CAS Number: 1000371-89-0
Other descriptive name: BAY 1007626
Concentration unit: mg milligram(s)
Conc
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent available before any study specific tests or procedures are performed. 2. Healthy female subject. 3. Willingness to use non-hormonal methods of contraception during the study. This applies during the cycle preceding the pre-treatment cycle until the end of follow-up. 4. Age at screening: 18–40 years inclusive. 5. Body mass index (BMI) at screening: = 18 and = 32 kg/m². 6. History of regular cyclic menstrual periods. 7. No clinically relevant abnormal findings in the pre-treatment endometrial biopsy. 8. Adequate venous access (frequent blood sampling). 9. Ability to understand and follow study-related instructions. 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 176 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Incompletely cured pre-existing diseases . 2. Any presence or history of known or suspected malignant Tumors 3. Any presence or history of known or suspected benign tumors of the liver or of the pituitary or adrenal gland. 4. History of recurrent vaginal infections. 5. Postpartum endometritis, infected abortion during the past three months before start of treatment 6. Hepatic disorders 7. Renal Disorders 8. Diseases associated with adverse vascular events . 9. Migraine . 10. Endogenous depression 11. Known current thyroid disorders. 12. Known hypersensitivity to the study medication . 13. Known clinically relevant severe allergies. 14. Amenorrhea . 15. Thrombophlebitis, venous / arterial thromboembolic diseases . 16. Regular use of medicines that might interfere with, for example, laboratory parameters, hormone metabolism. 17. Use of short-acting preparations containing sex hormones during the cycle preceding the pre-treatment cycle . 18. Use of long-acting preparations containing sex hormones within the 40 weeks before the first screening examination . 19. Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before the first study drug administration 20. Smoking of more than 10 cigarettes daily. 21. If the subject is a smoker: Subject is older than 35 years at the time of first screening visit. 22. Subject is a former smoker and has stopped smoking less than 3 months prior to the first screening visit. 23. Regular daily consumption of more than approximately 32 g of alcohol. 24. Suspicion of current drug, medicine or alcohol abuse. 25. Donation of blood or plasmapheresis after signing the informed consent form. 26. Clinically relevant ECG findings. 27. Systolic blood pressure 145 mmHg . 28. Diastolic blood pressure 90 mmHg . 29. Heart rate 100 beats/min. Physical and gynecological examination 30. Clinically relevant findings in the physical examination . 31. Menstrual disorders with suspicion of ovarian failure . 32. Known bleeding irregularities 33. Current or recurrent pelvic inflammatory disease, including pelvic inflammatory disease within 6 month prior to the insertion of the IUS and any active sexually transmitted disease. 34. Anovulatory pre-treatment cycle . 35. Clinically relevant findings in the gynecological examination, including inspection/palpation of the breast and transvaginal ultrasound examination 36. Abnormal cervical smear (details see section. 37. Acute genital infection. 38. Positive testing for Chlamydia trachomatis or Neisseria gonorrhea . 39. Undiagnosed vaginal bleeding. 40. Lack of suitability for IUS insertion and biopsy procedure due to congenital or acquired anatomical malformations of the uterus and/or findings/conditions that could increase the risks of the planned procedures. 41. Conditions associated with increased susceptibility to infections . 42. Lacking suitability for frequent TVU examinations. 43. Positive result of urine pregnancy test. 44. Positive results for hepatitis B virus surface antigen , hepatitis C virus antibodies , human immune deficiency virus antibodies . 45. Positive result of urine drug screening. 46. Clinically relevant deviations of the screened laboratory parameters from reference ranges. 47. Less than 3 months since delivery, abortion, or lactation before the first screening examination. 48. Participation in anot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate local and systemic effects of BAY 1007626 on: – Number of bleeding and spotting days, – Endometrial histology, – Ovulation (as surrogate for systemic effects). ;Primary end point(s): Primary Variables / Primary endpoints will be: • Number of bleeding and spotting days • Progestin effects on endometrial histology • Ovulation ;Secondary Objective: The secondary objective of this study is to assess the effects of BAY 1007626 on: – Endometrial thickness, – Serum levels of hormones: estradiol (E2), progesterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), – Cervix function (Insler score), – Bleeding pattern characterization, as well as the – Safety and tolerability of BAY 1007626, – PK of BAY 1007626 following intrauterine application, in comparison with Jaydess and Mirena. Data on PD and PK will be used to explore PK/PD relationship.;Timepoint(s) of evaluation of this end point: • Number of bleeding and spotting days (Daily recorded during the 90 days treatment period) • Progestin effects on endometrial histology (Data derived from biopsies taken pre-treatment, under treatment, during follow-up) • Ovulation (Under treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • Endometrial thickness (Repeatedly under treatment) • Bleeding characterization (Intensity, pattern), (For 90 day treatment period) • Serum levels of hormones (estradiol, progesterone, luteinizing hormone, follicle-stimulating hormone), (Repeatedly under treatment) • Cervix function (Insler score), (Repeatedly under treatment) • Treatment emergent AEs and SAEs (Continously);Secondary end point(s): Secondary Variables / Secondary endpoints will be: • Endometrial thickness • Bleeding characterization (Intensity, pattern) • Serum levels of hormones (estradiol, progesterone, luteinizing hormone, follicle-stimulating hormone) • Cervix function (Insler score) • Treatment emergent AEs and SAEs | — |
Countries
Germany, Netherlands, United Kingdom
Contacts
Public ContactBayer Clinical Trial Contact
Bayer AG
Outcome results
None listed