Effect of Piroxicam on Ovulation

Contraception, Postcoital Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320709
• Other study ID #: 14835
• Secondary ID: 2010-021195-28
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2011
• Last updated: July 9, 2015
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Contraception, Postcoital

Intervention

Drug:
• Piroxicam ( BAYl1902)
Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
• Piroxicam ( BAYl1902)
Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
• Placebo
Single dose of placebo (i.e., 4 placebo capsules)
• Piroxicam ( BAYl1902)
Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge		after 2 months	No
Secondary	course of follicle sizes		after 2 months	No
Secondary	course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)		after 2 months	No
Secondary	Concentration-times courses of piroxicam		after 2 months	No

External Links

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