Effect of Piroxicam on Ovulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception, Postcoital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Intervention Type DRUG

Piroxicam ( BAYl1902)

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Piroxicam ( BAYl1902)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes