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Levonorgestrel Emergency Pill

Phase 1

Contraception | Small molecule | Endocrine |Bayer AG|Last Updated: Apr 3, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Levonorgestrel Emergency Pill · 3 trials · 3 indications

Phase 1 3
NCT01073904Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mgContraceptives, Postcoital
COMPLETED32 Analytics
NCT01096485Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of LevonorgestrelContraception
COMPLETED24 Analytics
NCT01096498Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of LevonorgestrelContraception
COMPLETED24 Analytics
PHASE1COMPLETED
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
Contraceptives, PostcoitalUnlock trial analytics
PHASE1COMPLETED
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
ContraceptionUnlock trial analytics
PHASE1COMPLETED
Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Least square estimator of average maximum plasmatic concentration (log transformed)
After 2 months
Least square estimator of area under the pharmacokinetic curve (log transformed)
After 2 months

Secondary Endpoints

Time at which maximum concentration is reached
After 2 months
Area under the pharmacokinetic curve from time=0 to last blood sample
After 2 months
Half life of plasmatic concentration of study drug
After 2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Levonorgestrel Emergency Pill (BAY86-5028)DRUGSingle dose of 1.5 mg coated tablet
Postinor 2DRUGSingle dose of 1.5 mg tablet
Levonorgestrel Emergency Pill (BAY86-5028/Opxion)DRUGSingle dose of 1.5 mg coated tablet
Levonorgestrel (Postday)DRUGSingle dose of two 0.75 mg tablets
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis. Exclusion Criteria: * History of illnesses or any organic abnormalities that could affect the results of the stud...

Countries:Mexico
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Frequently asked questions about Levonorgestrel Emergency Pill

What is Levonorgestrel Emergency Pill used for?

Levonorgestrel Emergency Pill is used for postcoital contraception, commonly known as emergency contraception. It is a small molecule drug being developed by Bayer AG for the prevention of pregnancy after unprotected intercourse or contraceptive failure.

Who makes Levonorgestrel Emergency Pill?

Levonorgestrel Emergency Pill is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is being investigated for use in contraception and postcoital contraception.

What phase is Levonorgestrel Emergency Pill in?

Levonorgestrel Emergency Pill is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing clinical trials are designed to assess bioequivalence of different oral formulations.

What clinical trials is Levonorgestrel Emergency Pill in?

Levonorgestrel Emergency Pill has two completed Phase 1 clinical trials: NCT01073904 and NCT01096485. Both are cross-over studies conducted in Mexico to prove bioequivalence between two oral formulations of levonorgestrel 1.5 mg, enrolling healthy male volunteers aged 18 years and older.

Is Levonorgestrel Emergency Pill the same as levonorgestrel?

Levonorgestrel Emergency Pill is a formulation of levonorgestrel, a synthetic progestogen used for emergency contraception. The drug name refers to the specific product being developed by Bayer AG, which contains levonorgestrel as its active ingredient.