Effect of Piroxicam on Ovulation | NCT01320709

Studies
Effect of Piroxicam on Ovulation

NCT01320709

Sponsor

Bayer

Status

Completed

Last Update Posted

Jul 10, 2015Estimated

Enrollment

72Actual

Phase

Phase 2

Conditions

Contraception, Postcoital

Interventions

Piroxicam ( BAYl1902)
Piroxicam ( BAYl1902)
Placebo
Piroxicam ( BAYl1902)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-021195-28	EudraCT Number

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Mar 21, 2011

First Submission Date that Met QC Criteria

Mar 21, 2011

First Posted Date

Mar 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2015

Last Update Posted Date

Jul 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Piroxicam ( BAYl1902)	Drug	Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge		after 2 months

Secondary Outcomes

Measure	Description	Time Frame
course of follicle sizes		after 2 months
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)		after 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013843	Thiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring