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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901290
Recruitment Status : Suspended (suspended pending data analysis)
First Posted : May 13, 2009
Last Update Posted : December 10, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: monophasic oral contraceptive Drug: AZD7325 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1
monophasic oral contraceptive
Drug: monophasic oral contraceptive
mg, oral dose

Experimental: 2
Drug: AZD7325
mg, oral dose

Primary Outcome Measures :
  1. To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. 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 ]
  2. To characterize the steady-state pharmacokinetics of AZD7325 [ Time Frame: weekly ]
  3. To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN) [ Time Frame: weekly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901290

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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
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Principal Investigator: Eleanor Lisbon, MD, MPH Quintiles Phase I Services
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Responsible Party: MSD, AstraZeneca Identifier: NCT00901290    
Other Study ID Numbers: D1140C00018
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: October 2009
Keywords provided by AstraZeneca:
oral contraceptive
Additional relevant MeSH terms:
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Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female