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

NCT02490774 | Terminated Phase 2

• 2 other identifiers: 157312013-003980-74
• Study Type: interventional
• Target: 174
• Locations: 3 countries
• Sites: 7

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

Outcome Measures

Primary Outcomes (3)

• Number of bleeding and spotting days

  Daily recorded during 90 days treatment period

• 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.

  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).

• Ovulation(Yes/no)

  Treatment period 90 days

Secondary Outcomes (11)

• Endometrial thickness

  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

• Bleeding characterization (Intensity, pattern)

  For 90 day treatment period

• Serum levels of estradiol

  Repeatedly under 90 day treatment

• Serum levels of progesterone

  Repeatedly under 90 day treatment

• Serum levels of luteinizing hormone

  Repeatedly under 90 day treatment

Study Arms (6)

Arm 1: BAY1007626, low relase

EXPERIMENTAL

Intrauterine device with a low in vitro release rate

Drug: BAY1007626

Arm 2: BAY1007626, low to medium release

EXPERIMENTAL

Intrauterine device with a low to medium in vitro release rate

Drug: BAY1007626

Arm 3: BAY1007626, medium release

EXPERIMENTAL

Intrauterine device with a medium in vitro release rate

Drug: BAY1007626

Arm 4: BAY 1007626, high release

EXPERIMENTAL

Intrauterine device with a high in vitro release rate

Drug: BAY1007626

Arm 5: Levonorgestrel, Jaydess

ACTIVE COMPARATOR

Intrauterine device releasing levonorgestrel (Jaydess)

Drug: Jaydess

Arm 6: Levonorgestrel, Mirena

ACTIVE COMPARATOR

Intrauterine device releasing levonorgestrel (Mirena)

Drug: Mirena

Interventions

BAY1007626 DRUG

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

Arm 1: BAY1007626, low relase; Arm 2: BAY1007626, low to medium release; Arm 3: BAY1007626, medium release; Arm 4: BAY 1007626, high release

Jaydess DRUG

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

Arm 5: Levonorgestrel, Jaydess

Mirena DRUG

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

Arm 6: Levonorgestrel, Mirena

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Hanover, Lower Saxony, 30459, Germany

Location

Unknown Facility

Berlin, 10115, Germany

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Hamburg, 22159, Germany

Location

Unknown Facility

Hamburg, 22351, Germany

Location

Unknown Facility

Groningen, 9713GZ, Netherlands

Location

Unknown Facility

Belfast, BT2 7BA, United Kingdom

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: July 7, 2015
• Study Start: June 22, 2015
• Primary Completion: May 26, 2016
• Study Completion: July 22, 2016
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

DE (5); NL (1); GB (1)