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nomegestrol and estradiol

Phase 1

Healthy | Small molecule | Other |Organon & Co.|Last Updated: Feb 3, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00711607A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Contraception NOMAC-E2 (COMPLETED)(P05822)PHASE1 COMPLETED 25 — — May 1, 2007Sep 1, 2007Feb 3, 2022 - —
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Study Endpoints
Primary Endpoints
Plasma concentrations of NOMAC and serum concentrations of E2 and E1 measured at several time points before, during and after multiple dose and after single dose administration to determine pharmacokinetics
days 1 to 24, and days 34 - 42
Secondary Endpoints
Time-matched mean effects of QTcB, QTcF and QTcI values (respectively Bazett, Fredericia and Individual correction methods) compared to placebo, and time-matched changes from baseline
Screening (week -5), days 34, 35 and 42;
Drug safety as determined by gynecological and breast examination, trans vaginal ultrasound evaluation, pregnancy test, vital signs, ECG recordings, adverse events monitoring, routine laboratory parameters
From week -5 (screening) upto and including day 42 (followup)
Pharmacodynamics as determined by measuring serum concentrations of progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH) and sex hormone binding globulin (SHBG)
days 1 to 24, and days 34 - 42
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALGroup 1: NOMAC-E2 (days 1-24 and day 35)
2PLACEBO_COMPARATORGroup 2: NOMAC-E2 (days 1-24) followed by Placebo (day 35)
Interventions
NameTypeDescription
nomegestrol acetate and estradiolDRUGGroup 1: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 and day 35; Group 2: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 followed by one Placebo tablet on day 35
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Eligibility Criteria
Age Range18 Years — 50 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Fertile female subjects in good physical and mental health and 18 - 50 years of age at screening * Body mass index (BMI) of 17 ≤ BMI ≤ 29 kg/m2 * Able and willing to use non-hormonal contraceptives during the trial from screening up to follow up * With the last menstrual cycle...

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