stop_circleTerminated/Withdrawn
Contraception
Bayer Identifier:
15731
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
To investigate the pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development
Trial purpose
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development
Key Participants Requirements
Sex
FemaleAge
18 - 40 YearsTrial summary
Enrollment Goal
174Trial Dates
June 2015 - July 2016Phase
Phase 2Could I Receive a placebo
NoProducts
BAY100-7626Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Berlin, 10115, Germany | |
Completed | Berlin, 13353, Germany | |
Completed | Hamburg, 22159, Germany | |
Completed | Hamburg, 22351, Germany | |
Completed | Hannover, 30459, Germany | |
Withdrawn | Magdeburg, 39126, Germany | |
Completed | Belfast, BT2 7BA, United Kingdom | |
Completed | Groningen, 9713GZ, Netherlands |
Primary Outcome
- Number of bleeding and spotting daysdate_rangeTime Frame:Daily recorded during 90 days treatment periodenhanced_encryptionNoSafety Issue:
- Progestin effects on endometrial histologyEndometrail histology will be evaluated according to standardized criteria, derived from Blaustein’s standard pathology textbook and criteria for secretory-type effects caused by exogenous progestins after intrauterine application.date_rangeTime Frame:Data derived from biopsies taken in the pre-treatment cycle, under treatment (between day 42 and day 90 of treatment) and during follow-up (within max. 40 days after IUS removal).enhanced_encryptionNoSafety Issue:
- Ovulation(Yes/no)date_rangeTime Frame:Treatment period 90 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Endometrial thicknessdate_rangeTime Frame:pre-treatment cycle days 6, 9, 12, 15, 18, 21, 24, 27, 30, treatment period days 1, 13, 27, 41, 44, 48, 51, 55, 58, 62, 65, 69, 72, 76, 79, 83, 86, 90enhanced_encryptionNoSafety Issue:
- Bleeding characterization (Intensity, pattern)Classified using a 5-step scale from "none" to "heavy"date_rangeTime Frame:For 90 day treatment periodenhanced_encryptionNoSafety Issue:
- Serum levels of estradioldate_rangeTime Frame:Repeatedly under 90 day treatmentenhanced_encryptionNoSafety Issue:
- Serum levels of progesteronedate_rangeTime Frame:Repeatedly under 90 day treatmentenhanced_encryptionNoSafety Issue:
- Serum levels of luteinizing hormonedate_rangeTime Frame:Repeatedly under 90 day treatmentenhanced_encryptionNoSafety Issue:
- Serum levels of follicle-stimulating hormonedate_rangeTime Frame:Repeatedly under 90 day treatmentenhanced_encryptionNoSafety Issue:
- Cervix function (Insler score)The cervix function is classified using the 4-step Insler Scoredate_rangeTime Frame:cycle day 6,9,12,15,18,23,24,27,40, treatment period days 41,44,48,51,55,58,62,65,69,76,79,80,83,90enhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerability.date_rangeTime Frame:up to 5 monthsenhanced_encryptionYesSafety Issue:
- Cmax of BAY1007626date_rangeTime Frame:treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,enhanced_encryptionNoSafety Issue:
- AUC of BAY1007626date_rangeTime Frame:treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95enhanced_encryptionNoSafety Issue:
- T1/2 of BAY1007626date_rangeTime Frame:treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6