Clinical TrialID 7067

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)

NCT00711607

Healthy

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
7067
Evidence Id
7067
Core Evidence Id
7067
Source Clinical Trial Id
7058
Herb2 Clinical Trial Id
HBCT007058
Nct Id
NCT00711607
Title
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)
Status
Completed
Phase
Phase 1
Study Result
No
Study Condition
Healthy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Intervention
DRUG: nomegestrol acetate and estradiol
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Other
Gender
Female
Age
Adult
Enrollment
25
Outcome Measure
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
Sponsor Collaborator
Organon and Co|CRS Mannheim GmbH
Funded By
INDUSTRY
Location
Other Id
P05822|292006
Start Date
2007-05-01
Primary Completion Date
2007-09-01
Completion Date
2007-09-01
First Posted
2008-07-09
Results First Posted
Last Update Posted
2022-02-03
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00711607
Title Cn
Title En
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)
Bilingual Status
semi_complete