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Norgestimate/Ehinyl Estradiol; Folic acid

Phase 1

Female Contraception | Small molecule | Endocrine |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

Norgestimate/Ehinyl Estradiol; Folic acid · 1 trial · 4 indications

Phase 1 1
NCT00709189Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.Female Contraception
COMPLETED53 Analytics
PHASE1COMPLETED
Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
Female Contraception
NCT0070918953
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Study Endpoints

Primary Endpoints

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/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.

Secondary Endpoints

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/35 mcg EE. Safety also was assessed.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Interventions

NameTypeDescription
Norgestimate/Ehinyl 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/Ehinyl Estradiol; Folic acid

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

Norgestimate/Ethinyl Estradiol; Folic acid is an investigational small molecule being developed for female contraception. It is a combined oral contraceptive tablet containing norgestimate, ethinyl estradiol, and folic acid. The drug is intended for use in healthy women for contraceptive purposes, though it remains in clinical development and is not yet approved.

Who makes Norgestimate/Ethinyl Estradiol; Folic acid?

Johnson & Johnson (NYSE: JNJ) is developing Norgestimate/Ethinyl Estradiol; Folic acid. The company is conducting clinical trials to evaluate this oral contraceptive combination containing norgestimate, ethinyl estradiol, and folic acid for female contraception.

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

Norgestimate/Ethinyl Estradiol; Folic acid is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for female contraception, with one completed Phase 1 trial involving 53 healthy women.

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

Norgestimate/Ethinyl Estradiol; Folic acid has one completed clinical trial, NCT00709189, titled "Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women." This Phase 1 study enrolled 53 healthy female participants aged 18 years and older.

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

Norgestimate/Ethinyl Estradiol; Folic acid is a combination oral contraceptive that includes norgestimate and ethinyl estradiol plus folic acid. The clinical trial NCT00709189 compares the tablet with and without folic acid to assess bioequivalence. The drug is being studied for female contraception.