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

This study has suspended participant recruitment.
(suspended pending data analysis)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00901290
First received: May 12, 2009
Last updated: December 8, 2010
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Drug: monophasic oral contraceptive
Drug: AZD7325
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • To characterize the steady-state pharmacokinetics of AZD7325 [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: May 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
monophasic oral contraceptive
Drug: monophasic oral contraceptive
mg, oral dose
Other Name: ORTHO-CYCLEN
Experimental: 2
AZD7325
Drug: AZD7325
mg, oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901290

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Eleanor Lisbon, MD, MPH Quintiles Phase I Services
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00901290     History of Changes
Other Study ID Numbers: D1140C00018
Study First Received: May 12, 2009
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
oral contraceptive

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on April 14, 2014