An Open-label, Multi-center, Pharmacokinetic/Pharmacodynamic Study to Evaluate the Effect of a Single Dose of Levonorgestrel 1.5 mg Tablet on Ovulation Inhibition during Mid-follicular Phase in Underweight to Obese Women

Gedeon Richter Plc.0 sites520 target enrollmentJune 21, 2019

ConditionsOvulation MedDRA version: 20.0Level: PTClassification code 10036251Term: Post coital contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0Level: LLTClassification code 10033313Term: Ovulation inhibitedSystem Organ Class: 100000004860 Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

DrugsLevonelle® 1500 microgram tablet

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ovulation
Sponsor: Gedeon Richter Plc.
Enrollment: 520
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 21, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Gedeon Richter Plc.

Eligibility Criteria

Inclusion Criteria

•1\. Participants must have provided written informed consent before any study\-related procedure was performed and after having been informed about benefits and potential risks of the clinical study, as well as details of the insurance taken out to cover the healthy women participating in the clinical study.
•2\. Sex: female.
•3\. Age: \=18 years and \=40 years.
•4\. BMI: \=15 to \=42 kg/m2\.
•5\. Healthy women or women who have controlled stable chronic illness and are treated with medication, which does not interact with LNG 1\.5 mg tablet, or interfere with the ovulatory cycle. Prior to enrollment of women on medication, Sponsor or designee’s approval shall be obtained.
•6\. Healthy women with suitable veins for cannulation.
•7\. Participants must have normal physical and gynecological examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at screening or abnormal results that are judged to be not clinically significant by the Investigator and documented as such in the electronic case report form (eCRF).
•8\. Both ovaries visible upon TVUS examination at screening.
•9\. Regular menstrual cycles (every 21\-35 days) as established by participants’ medical history (during the past 3 months).
•10\. Menstrual cycle deemed normal by the gynaecologist.

Exclusion Criteria

•1\. Participants with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency, uncorrected hyper\- or hypothyroidism, acute systemic infection, gynecological, renal, gastrointestinal, respiratory, cardiovascular or hematological disease.
•2\. Screening liver enzyme test (aspartate aminotransferase \[AST] and/or alanine aminotransferase \[ALT]) results \=1\.5 x the upper limit of normal \[ULN] or total serum bilirubin \>1\.5 x ULN) (one repeat measurement is allowed).
•3\. Participants with gastrointestinal or renal disorders, including (but not limited to) severe malabsorption syndromes, such as Crohn's disease or colitis ulcerosa, which may interfere with the absorption, metabolism or excretion of the IMP in the Investigator’s opinion.
•4\. Participants with diseases or pathological findings of genital organs which might interfere with the ovulatory process, eg, ovarian cysts \>3\.0 cm, history of severe endometriosis, presence or history of pelvic inflammatory disease, that may confound the study results in the Investigator’s opinion.
•5\. History of current central nervous system (CNS) and/or psychiatric disorders which, in the Investigator’s opinion, may confound study results, requires treatment with prohibited medication, or may interfere with the participant’s compliance with study procedures. Participants with a diagnosis of any feeding and eating disorders are excluded.
•6\. Known allergy or sensitivity to levonorgestrel or the excipients of the IMP.
•7\. Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose\-galactose malabsorption.
•8\. Positive tests on anti\-human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M, or anti\-hepatitis C virus antibodies.
•9\. Known pituitary disorders, known adrenal disorders, or other significant, uncontrolled endocrine disorders including thyroid dysfunction and polycystic ovarian syndrome.
•10\. History or presence of unclarified vaginal bleeding.