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Ortho Tri-Cyclen LO

Phase 1

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 14, 2011

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Ortho Tri-Cyclen LO · 1 trial · 1 indication

Phase 1 1
NCT00399685Drug Interaction - Oral ContraceptiveHIV Infections
COMPLETED28 Analytics
PHASE1COMPLETED
Drug Interaction - Oral Contraceptive
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
throughout the study

Secondary Endpoints

Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen
throughout the study
Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels
throughout the study
Assess the safety of efavirenz coadministered with Ortho Cyclen
throughout the study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
CACTIVE_COMPARATOR -
DACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Ortho Tri-Cyclen LODRUGTablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
Ortho CyclenDRUGTablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
Ortho Cyclen + EfavirenzDRUGTablet, oral, OC + EFV 600 mg, once daily, 14 days.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

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...

Countries:United States
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Frequently asked questions about Ortho Tri-Cyclen LO

What is Ortho Tri-Cyclen LO used for?

Ortho Tri-Cyclen LO is a small molecule drug being studied for use in HIV Infections. It is currently in Phase 1 clinical development. The drug is being investigated for its potential role in the treatment of HIV, though it is not yet approved for this indication.

Who makes Ortho Tri-Cyclen LO?

Ortho Tri-Cyclen LO is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this drug for the treatment of HIV Infections.

What phase is Ortho Tri-Cyclen LO in?

Ortho Tri-Cyclen LO is in Phase 1 clinical development. It is an investigational drug being studied for HIV Infections. The drug is not yet approved and is still undergoing clinical trials to evaluate its safety and potential efficacy.

What clinical trials is Ortho Tri-Cyclen LO in?

Ortho Tri-Cyclen LO has one completed clinical trial, NCT00399685, which was a Phase 1 study titled "Drug Interaction - Oral Contraceptive." The trial enrolled 28 female participants in the United States and was active-controlled, though it was not randomized or double-blinded.

Is Ortho Tri-Cyclen LO FDA approved?

Ortho Tri-Cyclen LO is not FDA approved for HIV Infections. It is an investigational drug currently in Phase 1 clinical development. The drug has completed one clinical trial, but it remains under study and has not received regulatory approval for this use.