NCT01320709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 10, 2015

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

March 21, 2011

Last Update Submit

July 9, 2015

Conditions

Contraception, Postcoital

Keywords

Emergency contraceptionContraception

Outcome Measures

Primary Outcomes (1)

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

    after 2 months

Secondary Outcomes (3)

  • course of follicle sizes

    after 2 months

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

    after 2 months

  • Concentration-times courses of piroxicam

    after 2 months

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: Piroxicam ( BAYl1902)

Arm 2

EXPERIMENTAL
Drug: Piroxicam ( BAYl1902)

Arm 3

PLACEBO COMPARATOR
Drug: Placebo

Arm 4

EXPERIMENTAL
Drug: Piroxicam ( BAYl1902)

Interventions

Piroxicam ( BAYl1902)DRUG

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

Arm 1
PlaceboDRUG

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

Arm 3

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Interventions

Piroxicam

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

July 10, 2015

Record last verified: 2014-12

Locations

DE(1)