Recent Updates
Recently added Catalysts

Ortho Tri-Cyclen LO

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00399685Drug Interaction - Oral ContraceptivePHASE1 COMPLETED 28 — — Dec 1, 2006Aug 1, 2007Apr 14, 20112 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria
Competitive Landscape -Bacterial Infections 62 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15, ATM-AVI, BAT, Part A: ATM-AVI Single Dose, Cohorts 1-4, PG4 vaccine in Buffer 1 with low dose PA-001
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine, iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY
Zai Lab Ltd. Sponsored ADRZLAB1PHASE3Omadacycline, Moxifloxacin
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar, Sinovac PCV24, high-dose Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline /kg, Sulbactam /kg -Durlobactam /kg
BiomX LtdPHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Moderna, Inc.MRNA1PHASE2mRNA-1982
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 — AIGIV, CYFENDUS, Collection of samples
Abbott LaboratoriesABT1NAUndisclosed
Unlock Competitive Intelligence