Overview

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 Co

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
Female
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
CRS Mannheim GmbH
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Megestrol
Polyestradiol phosphate
Criteria
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 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

Exclusion Criteria:

- 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

- Present use or use during two months prior to the start of the trial medication of the
following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine,
topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole,
sex steroids (other than pre- and post treatment contraceptive method) and herbal
remedies containing hypericum perforatum (St. John's Wort)

- Present use or use within one month prior to screening of any agent that was known to
prolong the QT/QTc interval

- History of /or current risk factors for TdP (e.g. heart failure, hypokaliemia,
hypomagnesaemia, hypocalcaemia, family history of long QT syndrome, loss of
consciousness)