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CompletedNCT01320709Updated Jul 10, 2015

Effect of Piroxicam on Ovulation

A Phase 2 interventional study of Piroxicam ( BAYl1902) and Piroxicam ( BAYl1902) in Contraception, Postcoital, sponsored by Bayer. Completed at 1 site in Germany. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-10.

Sponsored by Bayer · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Contraception, Postcoital

Keywords

  • Emergency contraception
  • Contraception
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Piroxicam ( BAYl1902)

  • Experimental
    Arm 2

    Drug: Piroxicam ( BAYl1902)

  • Placebo comparator
    Arm 3

    Drug: Placebo

  • Experimental
    Arm 4

    Drug: Piroxicam ( BAYl1902)

Interventions

  • DrugPiroxicam ( BAYl1902)

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

  • DrugPiroxicam ( BAYl1902)

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

  • DrugPlacebo

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

  • DrugPiroxicam ( BAYl1902)

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

06

What researchers measure

Primary outcomes

  1. Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge

    Time frame: after 2 months

Secondary outcomes

  1. course of follicle sizes

    Time frame: after 2 months

  2. course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)

    Time frame: after 2 months

  3. Concentration-times courses of piroxicam

    Time frame: after 2 months

07

Study locations

1 site
  • Berlin, 13353, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01320709
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 22, 2011
Start date
Mar 2011
Primary completion
Mar 2012
Completion
May 2012
Last update
Jul 10, 2015

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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