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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00901290

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 I

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 February 09, 2012