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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02490774
• Other study ID #: 15731
• Secondary ID: 2013-003980-74
• Status: Terminated
• Phase: Phase 2
• Start date: June 22, 2015
• Est. completion date: July 22, 2016

Study information

• Verified date: June 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 174
• Est. completion date: July 22, 2016
• Est. primary completion date: May 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• BAY1007626
Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)
• Jaydess
Jaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day
• Mirena
Mirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding and spotting days		Daily recorded during 90 days treatment period
Primary	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).
Primary	Ovulation(Yes/no)		Treatment period 90 days
Secondary	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
Secondary	Bleeding characterization (Intensity, pattern)	Classified using a 5-step scale from "none" to "heavy"	For 90 day treatment period
Secondary	Serum levels of estradiol		Repeatedly under 90 day treatment
Secondary	Serum levels of progesterone		Repeatedly under 90 day treatment
Secondary	Serum levels of luteinizing hormone		Repeatedly under 90 day treatment
Secondary	Serum levels of follicle-stimulating hormone		Repeatedly under 90 day treatment
Secondary	Cervix function (Insler score)	The cervix function is classified using the 4-step Insler Score	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
Secondary	Number of participants with adverse events as a measure of safety and tolerability.		up to 5 months
Secondary	Cmax of BAY1007626		treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,
Secondary	AUC of BAY1007626		treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95
Secondary	T1/2 of BAY1007626		treatment period days 13,20,30,41,55,62,72, 90, 91, 92,93,95

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