check_circleStudy 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
  • - 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
  • - 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
72
Trial Dates
March 2011 - May 2012
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Piroxicam
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 13353, Germany

Primary Outcome

  • Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge
    date_rangeTime Frame:
    after 2 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • course of follicle sizes
    date_rangeTime Frame:
    after 2 months
    enhanced_encryption
    Safety Issue:
    No
  • course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
    date_rangeTime Frame:
    after 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Concentration-times courses of piroxicam
    date_rangeTime Frame:
    after 2 months
    enhanced_encryption
    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
4

Additional Information

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