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norelgestromin+ ethinyl estradiol; mercilon

Phase 3

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 Trials3
Total Enrollment4,762

FDA Designations

No designations recorded

Clinical trial landscape

norelgestromin+ ethinyl estradiol; mercilon · 3 trials · 2 indications

Phase 3 3
NCT00236769A Study of Efficacy and Safety With the Transdermal Contraceptive System.Contraception
COMPLETED1,751 Analytics
NCT00236782A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.Contraception
COMPLETED1,517 Analytics
NCT00236795A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.Contraception
COMPLETED1,494 Analytics
PHASE3COMPLETED
A Study of Efficacy and Safety With the Transdermal Contraceptive System.
ContraceptionUnlock trial analytics
PHASE3COMPLETED
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.
ContraceptionUnlock trial analytics
PHASE3COMPLETED
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.

Secondary Endpoints

Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information.
Cycle control and compliance were assessed with diary cards containing bleeding and dosing information.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
norelgestromin + ethinyl estradiolDRUG -
norelgestromin + ethinyl estradiol; mercilonDRUG -
norelgestromin + ethinyl estradiol; triphasil.DRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy women with regular menstrual cycles * sexually active and at risk of pregnancy * nonpregnant * acceptable body mass index (BMI) * last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since * sitting BP\<140mmHg/\<90mmHg * 1 normal men...

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Frequently asked questions about norelgestromin+ ethinyl estradiol; mercilon

What is norelgestromin + ethinyl estradiol (Mercilon) used for?

Norelgestromin + ethinyl estradiol, also known as Mercilon, is a combination contraceptive used for the prevention of pregnancy. It is being developed by Johnson & Johnson (JNJ) and is currently in Phase 3 clinical development for contraception, within the therapeutic area of endocrine disorders.

What does norelgestromin + ethinyl estradiol target?

Norelgestromin + ethinyl estradiol is a combination of two hormones: norelgestromin, a progestin, and ethinyl estradiol, an estrogen. These hormones work together to prevent ovulation and thicken cervical mucus, making it harder for sperm to reach the uterus. This combined mechanism provides effective contraception.

Who makes norelgestromin + ethinyl estradiol (Mercilon)?

Norelgestromin + ethinyl estradiol, also known as Mercilon, is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the NYSE under the ticker JNJ. The drug is currently in Phase 3 clinical trials for contraception.

What phase is norelgestromin + ethinyl estradiol (Mercilon) in?

Norelgestromin + ethinyl estradiol (Mercilon) is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 4,762 participants, all focused on contraception.

What clinical trials is norelgestromin + ethinyl estradiol (Mercilon) in?

Norelgestromin + ethinyl estradiol (Mercilon) has completed three Phase 3 clinical trials: NCT00236769, NCT00236782, and NCT00236795. These studies evaluated the efficacy and safety of the transdermal contraceptive system, with two trials comparing it against Mercilon and Triphasil, respectively. All trials enrolled healthy female participants aged 18 years and older.

Is norelgestromin + ethinyl estradiol the same as Mercilon?

Yes, norelgestromin + ethinyl estradiol is also known as Mercilon. The drug is a combination contraceptive being developed by Johnson & Johnson (JNJ) for the prevention of pregnancy. It is currently in Phase 3 clinical development, with three completed trials evaluating its efficacy and safety.