Trial Condition(s):
Contraception, Postcoital
Effect of piroxicam on ovulation
Bayer Identifier:
14835
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Bayer Pharma AG Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surgeTimeframe: after 2 months
Secondary Outcome
- course of follicle sizesTimeframe: after 2 months
- course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)Timeframe: after 2 months
- Concentration-times courses of piroxicamTimeframe: after 2 months
Additional Information
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