Effect of Piroxicam on Ovulation

Phase 2

Completed

• Conditions: Contraception, Postcoital
• Interventions: Drug: Piroxicam ( BAYl1902); Drug: Placebo

• Registration Number: NCT01320709
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2014-12
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Piroxicam ( BAYl1902)	-
Arm 3	Placebo	-
Arm 2	Piroxicam ( BAYl1902)	-
Arm 1	Piroxicam ( BAYl1902)	-

Primary Outcome Measures

Name	Time	Method
Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge	after 2 months

Secondary Outcome Measures

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