NCT00901290

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

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

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

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 10, 2010

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

May 12, 2009

Last Update Submit

December 8, 2010

Conditions

Pharmacokinetics

Keywords

oral contraceptive

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN

    weekly

Secondary Outcomes (3)

  • 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

    weekly

  • To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN)

    weekly

Study Arms (2)

1

EXPERIMENTAL

monophasic oral contraceptive

Drug: monophasic oral contraceptive

2

EXPERIMENTAL

AZD7325

Drug: AZD7325

Interventions

monophasic oral contraceptiveDRUG

mg, oral dose

Also known as: ORTHO-CYCLEN
1
AZD7325DRUG

mg, oral dose

2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

Moxifloxacin4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Eleanor Lisbon, MD, MPH

    Quintiles Phase I Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

December 10, 2010

Record last verified: 2009-10

Locations

US(1)