Determine the Effects of C-administration of AZD7325 and... | NCT00901290

Studies
Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects

NCT00901290

Sponsor

AstraZeneca

Status

Suspended

Last Update Posted

Dec 10, 2010Estimated

Enrollment

56Estimated

Phase

Phase 1

Conditions

Pharmacokinetics

Interventions

monophasic oral contraceptive
AZD7325

Countries

United States

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

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

suspended pending data analysis

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Sep 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

May 12, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 13, 2009Estimated

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

Dec 8, 2010

Last Update Posted Date

Dec 10, 2010Estimated

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

The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	monophasic oral contraceptive	Drug: monophasic oral contraceptive
2	Experimental	AZD7325	Drug: AZD7325

Interventions

Name	Type	Description	Arm Group Labels	Other Names
monophasic oral contraceptive	Drug	mg, oral dose	1	ORTHO-CYCLEN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN		weekly

Secondary Outcomes

Measure	Description	Time Frame
Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325		weekly
To characterize the steady-state pharmacokinetics of AZD7325

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

If previously pregnant, must be > 6 month post-partum at the time of randomization
Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2

Exclusion Criteria:

Use of any prescription medication within 14 days of screening
current smoker or history of smoking within the last 3 months prior to enrollment
Abnormal pap smear exam result within one year of enrollment.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eleanor Lisbon, MD, MPH	Quintiles Phase I Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Overland Park	Kansas		United States

Intervention Browse Module

MeSH Terms

ID	Term
D000077266	Moxifloxacin
C576237	4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided