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

NCT ID: NCT02490774

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-22
• Study Completion Date: 2016-07-22

Brief Summary

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

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: BAY1007626, low relase

Intrauterine device with a low in vitro release rate

Group Type: EXPERIMENTAL

BAY1007626

Intervention Type: DRUG

Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)

Arm 2: BAY1007626, low to medium release

Intrauterine device with a low to medium in vitro release rate

Group Type: EXPERIMENTAL

BAY1007626

Intervention Type: DRUG

Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)

Arm 3: BAY1007626, medium release

Intrauterine device with a medium in vitro release rate

Group Type: EXPERIMENTAL

BAY1007626

Intervention Type: DRUG

Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)

Arm 4: BAY 1007626, high release

Intrauterine device with a high in vitro release rate

Group Type: EXPERIMENTAL

BAY1007626

Intervention Type: DRUG

Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)

Arm 5: Levonorgestrel, Jaydess

Intrauterine device releasing levonorgestrel (Jaydess)

Group Type: ACTIVE_COMPARATOR

Jaydess

Intervention Type: DRUG

Jaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day

Arm 6: Levonorgestrel, Mirena

Intrauterine device releasing levonorgestrel (Mirena)

Group Type: ACTIVE_COMPARATOR

Mirena

Intervention Type: DRUG

Mirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day

Interventions

BAY1007626

Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)

Intervention Type: DRUG

Jaydess

Jaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day

Intervention Type: DRUG

Mirena

Mirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Hanover, Lower Saxony, Germany

Berlin, , Germany

Berlin, , Germany

Hamburg, , Germany

Hamburg, , Germany

Groningen, , Netherlands

Belfast, , United Kingdom

Countries

Germany; Netherlands; United Kingdom

Other Identifiers

2013-003980-74

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15731

Identifier Type: -

Identifier Source: org_study_id