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Norgestimate; Ethinyl Estradiol; Folic acid

Phase 1

Drug Interactions | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 8, 2011

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

Norgestimate; Ethinyl Estradiol; Folic acid · 3 trials · 6 indications

Phase 1 3
NCT00709982A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.Drug Interactions
COMPLETED47 Analytics
NCT00709644Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.Pharmacokinetics
COMPLETED54 Analytics
NCT00709332A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.Drug Interactions
COMPLETED47 Analytics
PHASE1COMPLETED
A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.
Drug Interactions
NCT0070998247
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PHASE1COMPLETED
Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
Pharmacokinetics
NCT0070964454
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PHASE1COMPLETED
A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.
Drug Interactions
NCT0070933247
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Study Endpoints

Primary Endpoints

Evaluate the pharmacokinetic drug interaction between folic acid and the study drug (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown product of NGM, norelgestromin (NGMN), and EE.
Determine the bioequivalence of NGM (as measured by the pharmacokinetics of its active breakdown product NGMN) and EE in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
Evaluate the pharmacokinetic drug interaction between folic acid and OC (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown products of NGM, (norelgestromin [NGMN], and norgestrel [NG]) and EE.

Secondary Endpoints

Measure the pharmacokinetics of the active metabolite of NGM, norgestrel (NG). Evaluate the effect of the study drug on the pharmacokinetics of folic acid. Assess the safety.
Determine the pharmacokinetics of NG in these 2 formulations; and to characterize the pharmacokinetics of plasma folate after the administration of folic acid alone or in combination with 250 mcg NGM/25 mcg EE. Safety also was assessed.
Safety is also assessed.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Norgestimate; Ethinyl Estradiol; Folic acidDRUG -
Norgestimate; Ethinyl Estradiol; Folic acid.DRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy, nonpregnant, nonlactating, nonsmoking women, weighing at least 110 pounds * With regular menstrual cycles * A body mass index between 16 and 29.9 kg/m2 * And having a hematocrit of at least 36% Exclusion Criteria: * History or presence of disorders commonly accepted...

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Frequently asked questions about Norgestimate; Ethinyl Estradiol; Folic acid

What is Norgestimate; Ethinyl Estradiol; Folic acid used for?

Norgestimate; Ethinyl Estradiol; Folic acid is an investigational combination being studied for pharmacokinetics and drug interactions. It is being evaluated in healthy women for contraception and therapeutic equivalency. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes Norgestimate; Ethinyl Estradiol; Folic acid?

Johnson & Johnson (NYSE: JNJ) is developing Norgestimate; Ethinyl Estradiol; Folic acid. The drug is a small molecule combination product currently in Phase 1 clinical trials. Johnson & Johnson is conducting studies to evaluate its pharmacokinetics and potential drug interactions.

What phase is Norgestimate; Ethinyl Estradiol; Folic acid in?

Norgestimate; Ethinyl Estradiol; Folic acid is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 94 healthy female participants. The drug is investigational and has not received FDA approval.

What clinical trials is Norgestimate; Ethinyl Estradiol; Folic acid in?

Norgestimate; Ethinyl Estradiol; Folic acid has completed two Phase 1 trials: NCT00709332, a drug interaction study in healthy women, and NCT00709644, a bioequivalence study of oral contraceptive tablets with or without folic acid. Both trials were completed and enrolled 47 and 54 participants, respectively.

Is Norgestimate; Ethinyl Estradiol; Folic acid the same as NGM/EE?

Yes, Norgestimate; Ethinyl Estradiol; Folic acid is also referred to as NGM/EE in clinical trial documentation. The combination includes norgestimate (NGM), ethinyl estradiol (EE), and folic acid. Clinical trials NCT00709332 and NCT00709644 use the NGM/EE abbreviation to describe the drug.