A study to evaluate the effect of Levonorgestrel-Emergency Contraception Tablet on Ovulation Inhibition in groups with a BMI that ranges underweight to obese
- Conditions
- OvulationMedDRA version: 20.0Level: PTClassification code 10036251Term: Post coital contraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10033313Term: Ovulation inhibitedSystem Organ Class: 100000004860Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2019-001143-43-GB
- Lead Sponsor
- Gedeon Richter Plc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 520
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.
11. Participants must agree to sexual abstinence or to use an acceptable birth control method during the study (from screening until the end of the treatment cycle).
12. Baseline cycle of 21-35 days in length, with ovulation documented by TVUS, and a progesterone level of 12 nmol/L or greater.
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 520
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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.
11. Existing cervicitis, vaginitis, or bleeding cervical erosions. Re-screening is possible if treated for vaginitis with a negative test-of-cure.
12. Abnormal cervical smear within 2 years of dosing or at screening.
13. Severe or chronic constipation.
14. History of drug abuse or positive drug or alcohol test at screening or at Treatment Day 1 prior to dosing. Exception: participants with positive urine drug screen (UDS) at screening for opiates may be enrolled at Investigator’s discretion if drug of abuse is out ruled and a legitimate cause (eg, poppy seeds consumption), that can be discontinued prior to further participation in the study, is identified and documented in source data by that Investigator.
15. Regular use of alcohol, ie, more than 21 units of alcohol per week (1 unit = 100 mL of wine, 250 mL of beer, or 25 mL of 40% alcohol) or alcohol abuse within 6 months prior to the screening visit.
16. Blood donation or other blood loss of more than 400 mL within the last 2 months prior to individual start of baseline cycle of the participant.
17. Participation in a clinical study during the last 2 months or within 5 times the half-life of the IMP (whichever is longer) prior to individual start of baseline cycle of the participant.
18. Taken strong or moderate CYP3A4 inhibitors or inducers within 30 days before administration of IMP until the last PK sampling.
19. Use of any sex hormone
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To assess the time to ovulation in the treatment cycle.<br>To explore the effect of body weight on ovulation and pharmacokinetics (PK) of Levonorgestrel (LNG;Primary end point(s): The primary efficacy endpoint of this study is ovulatory suppression failure (OSfailure) defined as ovulation within 5 days from IMP administration;Timepoint(s) of evaluation of this end point: 5 days post IMP Administration f;Main Objective: To assess the shape, direction, and strength of relationship between BMI and ovulatory suppression failure (OSfailure) in women with a BMI =15 to =42 kg/m2given a single dose of Levonorgestrel 1.5 mg tablet.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy endpoints of this study are:<br><br>Time to ovulation in treatment cycle.<br><br>Endocrine status (hormone levels of LH, follicle stimulating hormone [FSH], P4 and estradiol [E2]).<br>Dominant follicular diameter (assessed by TVUS).<br><br>Other Secondary End Point<br><br>LNG plasma concentration–time data<br>;Timepoint(s) of evaluation of this end point: Through out the study.