stop_circleTerminated/Withdrawn

Contraception

Bayer Identifier:

15731

ClinicalTrials.gov Identifier:

NCT02490774

EudraCT Number:

2013-003980-74

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

Female

Age

18 - 40 Years
  • - Healthy female subject.
    - 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.
    - Age at screening: 18–40 years inclusive.
    - Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m².
    - History of regular cyclic menstrual periods.
    - No clinically relevant abnormal findings in the pre-treatment endometrial biopsy.
  • -Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
    - Any presence or history of known or suspected malignant tumors, especially any known or suspected breast cancer or other progestin-sensitive cancer.
    - Any presence or history of known or suspected benign tumors of the liver or of the pituitary or adrenal gland.
    - Amenorrhea (with unknown reason, not amenorrhea due to hormonal treatment) for more than 3 months within the 6 months before the first screening examination.
    - Use of short-acting preparations containing sex hormones during the cycle preceding the pre-treatment cycle (oral, transdermal, intravaginal, IUS).
    - Use of long-acting preparations containing sex hormones within the 40 weeks before the first screening examination (any long-acting injectable or implant).
    Clinically relevant findings in the physical examination (e.g. pronounced varicosis, thrombophlebitis, and evidence of peripheral circulatory disturbances).
    Menstrual disorders with suspicion of ovarian failure (e.g., oligomenorrhea, amenorrhea, hypomenorrhea).
    - Known bleeding irregularities
    - 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.
    - Anovulatory pre-treatment cycle (ovulation has to be observed by day 27 at the latest).
    - Positive result of urine pregnancy test.

Trial summary

Enrollment Goal
174
Trial Dates
June 2015 - July 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
BAY100-7626
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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 days
    date_rangeTime Frame:
    Daily recorded during 90 days treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Progestin effects on endometrial histology
    Endometrail 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_encryption
    Safety Issue:
    No
  • Ovulation(Yes/no)
    date_rangeTime Frame:
    Treatment period 90 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Endometrial thickness
    date_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, 90
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding characterization (Intensity, pattern)
    Classified using a 5-step scale from "none" to "heavy"
    date_rangeTime Frame:
    For 90 day treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Serum levels of estradiol
    date_rangeTime Frame:
    Repeatedly under 90 day treatment
    enhanced_encryption
    Safety Issue:
    No
  • Serum levels of progesterone
    date_rangeTime Frame:
    Repeatedly under 90 day treatment
    enhanced_encryption
    Safety Issue:
    No
  • Serum levels of luteinizing hormone
    date_rangeTime Frame:
    Repeatedly under 90 day treatment
    enhanced_encryption
    Safety Issue:
    No
  • Serum levels of follicle-stimulating hormone
    date_rangeTime Frame:
    Repeatedly under 90 day treatment
    enhanced_encryption
    Safety Issue:
    No
  • Cervix function (Insler score)
    The cervix function is classified using the 4-step Insler Score
    date_rangeTime Frame:
    cycle day 6,9,12,15,18,23,24,27,40, treatment period days 41,44,48,51,55,58,62,65,69,76,79,80,83,90
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability.
    date_rangeTime Frame:
    up to 5 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Cmax of BAY1007626
    date_rangeTime Frame:
    treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,
    enhanced_encryption
    Safety Issue:
    No
  • AUC of BAY1007626
    date_rangeTime Frame:
    treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
    enhanced_encryption
    Safety Issue:
    No
  • T1/2 of BAY1007626
    date_rangeTime Frame:
    treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
    enhanced_encryption
    Safety Issue:
    No

Trial design

Multi-center, randomized, comparator-controlled, single-blind, parallel-group study to investigate the pharmacodynamics, pharmacokinetics and safety of an intrauterine system releasing BAY 1007626, as compared with Mirena and Jaydess, in a combined proof-of-concept and dose-finding study in healthy pre menopausal women treated for 90 days
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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