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)

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 1, 2007

Primary Completion Date

September 1, 2007

Study Completion Date

September 1, 2007

Conditions
Healthy
Interventions
DRUG

nomegestrol acetate and estradiol

Group 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

All Listed Sponsors
collaborator

CRS Mannheim GmbH

UNKNOWN

lead

Organon and Co

INDUSTRY

NCT00711607 - 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) | Biotech Hunter | Biotech Hunter