Effect of Piroxicam on Ovulation

July 9, 2015 updated by: Bayer

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)
Experimental: Arm 2
Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)
Experimental: Arm 4
Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)
Placebo Comparator: Arm 3
Single dose of placebo (i.e., 4 placebo capsules)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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