Clinical trial NCT01320709: Effect of Piroxicam on Ovulation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception, Postcoital
Keywords: Emergency contraception
Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge
timeFrame: after 2 months
Secondary outcomes:
measure: course of follicle sizes
timeFrame: after 2 months
measure: course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
timeFrame: after 2 months
measure: Concentration-times courses of piroxicam
timeFrame: after 2 months
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: