Drug Interaction - Oral Contraceptive - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00399685

Purpose

The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.

Condition	Intervention	Phase
HIV Infections	Drug: Ortho Tri-Cyclen LO Drug: Ortho Cyclen Drug: Ortho Cyclen + Efavirenz	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Study to Evaluate the Effect of Efavirenz Coadministration on the Pharmacokinetics of the Active Moieties of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Drug Reactions HIV/AIDS

Drug Information available for: Estradiol Ethinyl estradiol Norgestimate Moxifloxacin Efavirenz Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen [ Time Frame: throughout the study ]
Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels [ Time Frame: throughout the study ]
Assess the safety of efavirenz coadministered with Ortho Cyclen [ Time Frame: throughout the study ]

Enrollment:	28
Study Start Date:	December 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: Ortho Tri-Cyclen LO Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
Active Comparator: B	Drug: Ortho Cyclen Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
Active Comparator: C	Drug: Ortho Cyclen + Efavirenz Tablet, oral, OC + EFV 600 mg, once daily, 14 days. Other Name: Sustiva
Active Comparator: D	Drug: Ortho Cyclen Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
Documented acceptable Pap smear within 1 year of the start of the study
BMI of 18-32 kg/m²

Exclusion Criteria:

Males
Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
History of conditions in which oral contraceptives are contraindicated
History of migraine with focal aura
History of uncontrolled hypertension
Positive screening test for HIV-1,-2, HIV viral RNA, Hepatitis B surface antigen, or Hepatitis C antibody
History of diagnosed mental illness or suicidal ideation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399685

Locations

United States, California
Covance Clinical Research Unit San Diego
San Diego, California, United States, 92123
United States, Washington
Northwest Kinetics
Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00399685 History of Changes
Other Study ID Numbers:	AI266-145
Study First Received:	November 14, 2006
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Contraceptives, Oral, Combined

Efavirenz
Moxifloxacin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012