Drug Interaction - Oral Contraceptive
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ClinicalTrials.gov Identifier: NCT00399685 |
Recruitment Status
:
Completed
First Posted
: November 15, 2006
Last Update Posted
: April 14, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Ortho Tri-Cyclen LO Drug: Ortho Cyclen Drug: Ortho Cyclen + Efavirenz | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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 ]
- 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 ]

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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:
- 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

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 ClinicalTrials.gov identifier (NCT number): NCT00399685
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 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00399685 History of Changes |
Other Study ID Numbers: |
AI266-145 |
First Posted: | November 15, 2006 Key Record Dates |
Last Update Posted: | April 14, 2011 |
Last Verified: | April 2011 |
Keywords provided by Bristol-Myers Squibb:
HIV |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Contraceptive Agents Norgestimate, ethinyl estradiol drug combination Efavirenz Moxifloxacin Fluoroquinolones Contraceptives, Oral |
Reproductive Control Agents Physiological Effects of Drugs Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |