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
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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