- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01320709
Effect of Piroxicam on Ovulation
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 13353
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Piroxicam
Other Study ID Numbers
- 14835
- 2010-021195-28 (EudraCT Number)
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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