Multicenter, randomized and single-blind (group assigned by chance and unknown to study subjects), comparator-controlled study with all groups running in parallel to investigate the pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY 1007626 as compared to Mirena and Jaydess in healthy pre-menopausal women treated for 90 days to determine the study drug dose for further development

Phase 1

• Conditions: Contraception; MedDRA version: 18.0Level: LLTClassification code 10010809Term: Contraception NOSSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2013-003980-74-NL
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-18
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 176

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

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 < 90 or > 145 mmHg .
28.Diastolic blood pressure < 50 or > 90 mmHg .
29.Heart rate < 45 or > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified