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 | Completed Phase 1

• 2 other identifiers: P05822292006
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2

Conditions

Healthy

Keywords

pharmacokinetics (PK); combined oral contraceptive; nomegestrol acetate; estradiol; NOMAC; E2; NOMAC-E2; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

Group 1: NOMAC-E2 (days 1-24 and day 35)

Drug: nomegestrol acetate and estradiol

2

PLACEBO COMPARATOR

Group 2: NOMAC-E2 (days 1-24) followed by Placebo (day 35)

Drug: nomegestrol acetate and estradiol

Interventions

nomegestrol acetate and estradiol DRUG

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

Also known as: NOMAC-E2; Org 10486-0 + Org 2317

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 of 28 +/- 7 days
• Able and willing to sign the informed consent form
• Able to refrain from smoking, grapefruit containing products, and all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) during hospitalization and during pharmacokinetic sampling on days 24-30 and days 35-41

You may not qualify if:

• History of sensitivity/idiosyncrasy to NOMAC-E2 or chemically related compounds or excipients which could be employed within the study or to any other unknown drug used in the past
• Use of any drug or substance within one week prior to the first treatment day, except paracetamol
• Clinically relevant history or presence of any medical disorder
• Clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening (and just prior to dosing)
• Known or suspected pregnancy
• History of/or current abuse of drugs or alcohol or solvents, or positive drug or alcohol screen at screening and admission, as judged by the investigator
• Positive test result on hepatitis B surface antigen, hepatitis C antibody, or HIV 1/2 serology
• Participation in an investigational drug study within 90 days prior to treatment day 1
• Donation of blood within 90 days prior to treatment day 1
• Contra-indications of contraceptive steroids (general)
• Abnormal cervical smear at screening, or documentation of abnormal smear performed within 12 months before screening
• Clinically relevant transvaginal ultrasound pathology or inability to undergo transvaginal ultrasound evaluation
• Use of an injectable hormonal method of contraception; within 6 months of an injectable with a 3-month duration, within 4 months of an injectable with a 2-month duration, within 2 months of an injectable with a 1-month duration
• Before spontaneous menstruation has occurred following a delivery or abortion
• Breastfeeding or within 2 months after stopping breast feeding prior to start of trial medication

Sponsors & Collaborators

• Organon and Co: lead
• CRS Mannheim GmbH: collaborator

Related Publications (1)

• Gerrits MG, Schnabel PG, Post TM, Peeters PA. Pharmacokinetic profile of nomegestrol acetate and 17beta-estradiol after multiple and single dosing in healthy women. Contraception. 2013 Feb;87(2):193-200. doi: 10.1016/j.contraception.2012.07.001. Epub 2012 Aug 13.

  PMID: 22898360 RESULT

MeSH Terms

Interventions

nomegestrol acetate; Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: May 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: February 3, 2022

Record last verified: 2022-02