Recent Updates
Recently added Catalysts

levonorgestrel, efavirenz

Phase 1

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jul 15, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

levonorgestrel, efavirenz · 1 trial · 3 indications

Phase 1 1
NCT00482963A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV MedicationHIV Infections
COMPLETED24 Analytics
PHASE1COMPLETED
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
12 hour pharmacokinetic study

Secondary Endpoints

Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
12 hour pharmacokinetic study
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
3 weeks
Changes in liver function tests before and during efavirenz
3 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
levonorgestrel, efavirenzEXPERIMENTALhealthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz

Interventions

NameTypeDescription
levonorgestrel, efavirenzDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy, HIV-1 seronegative women of child-bearing age. Exclusion Criteria: * Current use of hormonal contraception * Pregnancy/Breast Feeding * Post-menopausal status * Obesity * Hepatitis B or C * Psychiatric illness * Active Substance Abuse

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about levonorgestrel, efavirenz

What is levonorgestrel, efavirenz used for?

Levonorgestrel, efavirenz is a combination of a hormonal emergency contraceptive and an HIV medication, studied for use in HIV infections and contraception. It is a small molecule drug being developed by Bristol-Myers Squibb Company. The drug is currently in Phase 1 clinical development and is investigational, not yet approved.

What does levonorgestrel, efavirenz target?

The specific molecular targets of levonorgestrel, efavirenz are not disclosed in the available information. The drug combines levonorgestrel, a progestin hormone used for emergency contraception, and efavirenz, an antiretroviral medication used to treat HIV. Its clinical study focuses on drug interactions between these components in HIV-infected women.

Who makes levonorgestrel, efavirenz?

Levonorgestrel, efavirenz is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this combination therapy for HIV infections and contraception.

What phase is levonorgestrel, efavirenz in?

Levonorgestrel, efavirenz is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 24 participants, but the drug remains in early-stage clinical testing.

What clinical trials is levonorgestrel, efavirenz in?

Levonorgestrel, efavirenz has one completed clinical trial registered as NCT00482963, titled 'A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication.' This Phase 1 study enrolled 24 female participants in the United States, including healthy volunteers, and examined pharmacokinetics in the context of HIV infections and contraception.

Is levonorgestrel, efavirenz the same as Plan B or Sustiva?

Levonorgestrel, efavirenz is a combination of two existing drugs: levonorgestrel, the active ingredient in emergency contraceptives like Plan B, and efavirenz, an antiretroviral sold under the brand name Sustiva. However, this specific combination product is a distinct investigational drug being studied by Bristol-Myers Squibb, not a marketed formulation.