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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014