Emergency Contraception
Conditions
Interventions
Trade Name: Piroxicam
Product Name: Piroxicam Hexal 2*10mg encapsulated tablets
Product Code: BAY l1902
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Piroxicam
Other descriptive name: Pirox
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Signed informed consent available before any study specific tests or procedures are performed •Healthy female subject •Age: 18 to 35 years (inclusive) at the first screening visit •Body mass index (BMI ): 18-30 kg/m² (inclusive) at the first screening visit •Confirmation of the subject’s health insurance coverage prior to the first screening visit •Willingness to use non-hormonal methods of contraception during the study •Ability to understand and follow study-related instructions •Adequate venous access 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 •Known or suspected malignant tumors •Known or suspected benign tumors of the liver, pituitary, and adrenal gland •Known hypersensitivity to piroxicam, to other oxicam compounds, or to any of the excipients of the study medication •Known reactions in the form of bronchospasm, asthma, rhinitis, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past •History of any type of serious (allergic) reaction to medicinal products, particularly skin reactions such as erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis •Hypersensitivity to the active substance or skin reactions to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past •Unexplained haemopoietic or clotting disorders •Known current thyroid disorders which require treatment •Known diseases of the gastrointestinal tract that predispose to bleeding, such as ulcerative colitis, Crohn’s disease, or diverticulitis •History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation •Presence of frequent heartburn indicative of gastroesophageal reflux disease •Intolerance to lactose requiring strictly lactose-free diet and restriction to lactose-free oral medicines (hereditary galactose intolerance, galactose-glucose malabsorption, lactase deficiency) •History or presence of suffering from hay fever •Cerebrovascular or other active bleeds •Severe hepatic dysfunction or impaired renal function •Moderate or severe heart failure •Regular intake of medication other than hormonal contraceptives •Use of drugs affecting the synthesis of prostaglandins (especially NSAIDs) during the relevant time period (the relevant time period comprises: the day with the onset of LH surge including the two preceding days, plus the following days until ovulation is clearly observed – or until the next menstrual bleeding) •Use of short-acting hormonal contraceptives during the cycle preceding the pre-treatment cycle •Use of long-acting hormonal contraceptives within 40 weeks prior to the start of the pre-treatment cycle •Present use of an IUD releasing hormones; in case of recent use of an IUD releasing hormones, at least one complete menstrual cycle should have elapsed after its removal before starting the pre-treatment cycle (copper IUDs are acceptable) •Regular use of therapeutic or recreational drugs •Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks prior to the study drug administration •Suspicion of or known current drug or alcohol abuse •Heavy smokers with a daily consumption of > 25 cigarettes •Donation of whole blood or components of blood after signing the informed consent form •Systolic blood pressure below 95 or above 140 mmHg (after resting for at least 3 min in sitting position) •Diastolic blood pressure below 50 or above 90 mmHg (after resting for at least 3 min in sitting position) •Heart rate (HR) below 45 or above 95 beats / min (after resting for at least 3 min in sitting position) •Clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure •Menstrual disorders suspicious of ovarian failure •Clinically relevant fin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Describe the course of follicle sizes Investigate the course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone) Investigate the pharmacokinetics (PK) of piroxicam Investigate the correlation of serum concentrations of piroxicam and pharmacodynamic effects (PK/PD analysis), if applicable ;Primary end point(s): The primary efficacy variable will be the proportion of subjects with delay of ovulation (responder) or ovulation inhibition (responder).;Main Objective: To assess whether piroxicam has an effect on ovulation (delay or inhibition) when given after the onset of LH surge | — |
Countries
Germany
Contacts
Public ContactCTP Team/Ref:"EU CTR"/
Bayer HealthCare AG
Outcome results
None listed