Drug Interaction - Oral Contraceptive
|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.|
|ClinicalTrials.gov Identifier: NCT00399685|
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : April 14, 2011
|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|
|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|
|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 ]
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|
|Tacoma, Washington, United States, 98418|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|