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Norgestimate/Ehinyl Estradiol; Folic acid

Phase 1

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

Norgestimate/Ehinyl Estradiol; Folic acid development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2008

Norgestimate/Ehinyl Estradiol; Folic acid target and mechanism

Molecular targetPGR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Norgestimate/Ehinyl Estradiol; Folic acid clinical trials

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 ContraceptionUnlock trial analytics

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 with folic acid?

Norgestimate/ethinyl estradiol with folic acid is an investigational oral contraceptive combination that pairs the progestin norgestimate and the estrogen ethinyl estradiol with folic acid. It is being developed by Johnson & Johnson (ticker JNJ) and is in Phase 1 clinical development for contraception.

What does norgestimate/ethinyl estradiol target?

Norgestimate/ethinyl estradiol targets the progesterone receptor (PGR), where it acts as an agonist. Norgestimate is the progestin component and ethinyl estradiol is the estrogen component; together they act on hormonal pathways to suppress ovulation and support contraceptive effect. Folic acid is included as a supplemental vitamin rather than as a hormonal agent.

Who makes norgestimate/ethinyl estradiol with folic acid?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of norgestimate/ethinyl estradiol with folic acid. The product is an oral contraceptive tablet combining norgestimate, ethinyl estradiol, and folic acid, and it remains in clinical development.

What phase is norgestimate/ethinyl estradiol with folic acid in?

Norgestimate/ethinyl estradiol with folic acid is in Phase 1 clinical development. It is an investigational product and is not approved; the only recorded trial is a completed Phase 1 study. No active trials are currently listed for this asset.

What clinical trials is norgestimate/ethinyl estradiol with folic acid in?

One trial is recorded for norgestimate/ethinyl estradiol with folic acid: NCT00709189, a completed Phase 1 bioequivalence study of the oral contraceptive tablet containing norgestimate and ethinyl estradiol with or without folic acid in healthy women. It enrolled 53 participants, was randomized, and was uncontrolled.