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nomegestrol and estradiol

Phase 1

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

nomegestrol and estradiol · 1 trial · 1 indication

Phase 1 1
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)Healthy
COMPLETED25 Analytics
PHASE1COMPLETED
A 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)
Healthy
NCT0071160725
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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 to 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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Frequently asked questions about nomegestrol and estradiol

What is Nomegestrol used for?

Nomegestrol is an investigational small molecule being studied for use in healthy volunteers and for contraception. It is being developed by Organon & Co. (NYSE: OGN) and is currently in Phase 2 clinical development for contraception.

Who makes Nomegestrol?

Nomegestrol is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The drug is currently in Phase 2 clinical development for contraception.

What phase is Nomegestrol in?

Nomegestrol is in Phase 2 clinical development for contraception. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for the drug are ongoing or completed, with one Phase 2 trial completed.

What clinical trials is Nomegestrol in?

Nomegestrol has been studied in clinical trials including NCT00711607, a Phase 1 pharmacokinetic study in healthy volunteers, and NCT01709318, a Phase 2 dose-finding study for contraception. Both trials have been completed.

Is Nomegestrol the same as Nomegestrol acetate?

Nomegestrol is related to Nomegestrol acetate, a progestin used in hormonal contraception. Clinical trials for Nomegestrol have evaluated Nomegestrol acetate in combination with estradiol for contraceptive purposes.