check_circleStudy Completed
Contraception, Postcoital
Bayer Identifier:
14835
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Effect of piroxicam on ovulation
Trial 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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
72Trial Dates
March 2011 - May 2012Phase
Phase 2Could I Receive a placebo
YesProducts
PiroxicamAccepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bayer Pharma AG | Berlin, 13353, Germany |
Primary Outcome
- Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surgedate_rangeTime Frame:after 2 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- course of follicle sizesdate_rangeTime Frame:after 2 monthsenhanced_encryptionNoSafety Issue:
- course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)date_rangeTime Frame:after 2 monthsenhanced_encryptionNoSafety Issue:
- Concentration-times courses of piroxicamdate_rangeTime Frame:after 2 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4