Effect of Piroxicam on Ovulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01320709
First received: March 21, 2011
Last updated: September 5, 2014
Last verified: September 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01320709     History of Changes
Other Study ID Numbers: 14835, 2010-021195-28
Study First Received: March 21, 2011
Last Updated: September 5, 2014
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 September 18, 2014