Effect of Piroxicam on Ovulation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Contraception, Postcoital	Drug: Piroxicam ( BAYl1902) Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Piroxicam

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge [ Time Frame: after 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

course of follicle sizes [ Time Frame: after 2 months ] [ Designated as safety issue: No ]
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone) [ Time Frame: after 2 months ] [ Designated as safety issue: No ]
Concentration-times courses of piroxicam [ Time Frame: after 2 months ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	March 2011
Study Completion Date:	May 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Piroxicam ( BAYl1902) Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
Experimental: Arm 2	Drug: Piroxicam ( BAYl1902) Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
Placebo Comparator: Arm 3	Drug: Placebo Single dose of placebo (i.e., 4 placebo capsules)
Experimental: Arm 4	Drug: Piroxicam ( BAYl1902) Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320709

Locations

Germany

Berlin, Germany, 13353

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT01320709 History of Changes
Other Study ID Numbers:	14835, 2010-021195-28
Study First Received:	March 21, 2011
Last Updated:	September 4, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Emergency contraception
Contraception

Additional relevant MeSH terms:

Piroxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013