Phase
Condition
Obesity
Hypertriglyceridemia
Treatment
Microgynon®
BI 456906
Clinical Study ID
Ages 18-60 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Otherwise healthy women according to the assessment of the investigator, as based ona complete medical history including a physical examination, vital signs (bloodpressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinicallaboratory tests
Age of 18 to 60 years (inclusive)
Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive)
Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial, i.e. prior to starting any screening procedures
Subject fulfills any of the following criteria at least 4 weeks prior to allocationof subject number (i.e. prior to Day 1 of period 1):
Use of non-hormone releasing intrauterine device (IUD) and male partner must bevasectomised (provided that partner is the sole sexual partner of the trialparticipant) with documented absence of sperm or use a condom
Bilateral tubal ligation and male partner must be vasectomised (provided thatpartner is the sole sexual partner of the trial participant) with documentedabsence of sperm or use a condom
Sexually abstinent (i.e. subjects must abstain from male-female sex)
Surgically sterilised (including hysterectomy, bilateral salpingectomy,bilateral oophorectomy)
Postmenopausal, defined as no menses for 1 year without an alternative medicalcause (in questionable cases a blood sample with levels of follicle stimulatinghormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
Exclusion
Exclusion Criteria:
Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance and/or liver enzymes (alanine transaminase (ALT), aspartateaminotransferase (AST), gamma-glutamyl transpeptidase (GGT)) and/or pancreaticenzymes (amylase lipase) above upper limit of normal range +10% at screeningexamination, confirmed by a repeat test
Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,immunological or hormonal disorders
History of either chronic or acute pancreatitis
Cholecystectomy, and/or prior surgery of the gastrointestinal (GI) tract (includingbariatric surgery) or any relevant anatomical malformation of the GI tract thatcould interfere with the pharmacokinetics of the trial medication (investigationalmedicinal product (IMP) or auxiliary medicinal product (AxMP)) - except appendectomyor simple hernia repair
Diseases of the central nervous system (including but not limited to any kind ofseizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts Furtherexclusion criteria apply
Study Design
Connect with a study center
Charité Research Organisation GmbH
Berlin, 10117
GermanySite Not Available
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