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Effect of Piroxicam on Ovulation

NCT01320709 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-07-10

No results posted yet for this study

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.

Conditions

  • Contraception, Postcoital

Interventions

DRUG

Piroxicam ( BAYl1902)

Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)

DRUG

Piroxicam ( BAYl1902)

Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)

DRUG

Placebo

Single dose of placebo (i.e., 4 placebo capsules)

DRUG

Piroxicam ( BAYl1902)

Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-03-31
Completion
2012-05-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320709 on ClinicalTrials.gov