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Drug Interaction - Oral Contraceptive
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00399685
First received: November 14, 2006
Last updated: April 13, 2011
Last verified: April 2011
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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:
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 (Adult) |
| Sexes 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
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: NCT00399685
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 | Bristol-Myers Squibb |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00399685 History of Changes |
| Other Study ID Numbers: |
AI266-145 |
| Study First Received: | November 14, 2006 |
| Last Updated: | April 13, 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 Norgestimate, ethinyl estradiol drug combination Contraceptive Agents Contraceptives, Oral Moxifloxacin Fluoroquinolones Efavirenz |
Contraceptives, Oral, Combined Contraceptive Agents, Female Reproductive Control Agents Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nucleic Acid Synthesis Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Antiviral Agents |
ClinicalTrials.gov processed this record on June 23, 2017