Study Completed

Contraception, Postcoital

Bayer Identifier:

14835

ClinicalTrials.gov Identifier:

NCT01320709

EudraCT Number:

2010-021195-28

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

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

March 2011 - May 2012

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Piroxicam

Accepts Healthy Volunteer

Yes

Where 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 surge
Time Frame:
after 2 months
Safety Issue:
No

Secondary Outcome

course of follicle sizes
Time Frame:
after 2 months
Safety Issue:
No
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
Time Frame:
after 2 months
Safety Issue:
No
Concentration-times courses of piroxicam
Time Frame:
after 2 months
Safety Issue:
No

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for websynopsis results provided by Bayer