Effect of Piroxicam on Ovulation

Study Overview
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Brief Summary
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In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation). Additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition the concentration of piroxicam in blood will be determined in regular intervals. With regards to the tolerability of the study drug subjects will be asked regularly how they feel.

Official Title
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Single-center, Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Evaluate Whether a Single-dose of Either 20 mg Piroxicam, 40 mg Piroxicam or 80 mg Piroxicam Shows an Effect on Ovulation After the Onset of LH Surge Compared to Placebo in Healthy Young Women

Conditions
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Contraception, Postcoital

Intervention / Treatment
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* Drug: Piroxicam ( BAYl1902)
* Drug: Piroxicam ( BAYl1902)
* Drug: Placebo
* Drug: Piroxicam ( BAYl1902)


Participation Criteria
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Eligibility Criteria
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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 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 Hypersensitivity to the active substance or skin reactions (irrespective of severity) to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past History or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation Regular intake of medication other than hormonal contraceptives Clinically relevant findings in the gynecological examination including transvaginal ultrasound (TVU) Clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure Time point onset of LH surge in the pre-treatment cycle not determinable Time point ovulation in the pre-treatment cycle not determinable Lacking suitability for frequent TVU examinations History or presence of suffering from hay fever

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Piroxicam ( BAYl1902)<br>* Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)<br>|
| Experimental: Arm 2<br> | Drug: Piroxicam ( BAYl1902)<br>* Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Single dose of placebo (i.e., 4 placebo capsules)<br>|
| Experimental: Arm 4<br> | Drug: Piroxicam ( BAYl1902)<br>* Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge |  | after 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| course of follicle sizes |  | after 2 months | 
| course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone) |  | after 2 months | 
| Concentration-times courses of piroxicam |  | after 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency contraception, Contraception