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Effect of Piroxicam on Ovulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01320709
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Contraception, Postcoital Drug: Piroxicam ( BAYl1902) Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2011
Primary Completion Date : March 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
Drug Information available for: Piroxicam
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge [ Time Frame: after 2 months ]

Secondary Outcome Measures :
  1. course of follicle sizes [ Time Frame: after 2 months ]
  2. course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone) [ Time Frame: after 2 months ]
  3. Concentration-times courses of piroxicam [ Time Frame: after 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320709


Locations
Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01320709     History of Changes
Other Study ID Numbers: 14835
2010-021195-28 ( EudraCT Number )
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: December 2014

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action