Clinical trial NCT00563472 (phase 2, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: estetrol, estetrol, estetrol and desogestrel, estetrol and progesterone
SMILES: [H][C@@]1(O)[C@]([H])(O)[C@@]2([H])[C@]3([H])CCC4=CC(O)=CC=C4[C@@]3([H])CC[C@]2(C)[C@@]1([H])O, [H][C@@]1(O)[C@]([H])(O)[C@@]2([H])[C@]3([H])CCC4=CC(O)=CC=C4[C@@]3([H])CC[C@]2(C)[C@@]1([H])O, [H][C@@]1(O)[C@]([H])(O)[C@@]2([H])[C@]3([H])CCC4=CC(O)=CC=C4[C@@]3([H])CC[C@]2(C)[C@@]1([H])O, [H][C@@]12CC[C@H](C(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years and not older than 40 years of age

          -  Willing to use a barrier method of contraception during the wash-out cycle, the
             pre-treatment cycle, the period of study drug administration, the period of
             lynestrenol intake (if applicable), and 14 days thereafter or until the follow-up
             visit if this 14-days period ends before the follow-up visit.

          -  Women who ovulate in the pre-treatment cycle before or on day 24 (±1) after start of
             their menses, who have a subsequent P concentration of > 16 nmol/l and whose next
             menstruation does not start within 6 days after ovulation

          -  Body Mass Index > 18 and <30 kg/m2

          -  Good physical and mental health

          -  Both ovaries visible upon ultrasonography

          -  Willing to give informed consent in writing

        Exclusion Criteria:

          -  Clinically significant abnormal results of routine hematology, serum biochemistry,
             urinanalysis, and/or ECG in the opinion of the Investigator at screening.

          -  Known or suspected pregnancy

          -  Lactation

          -  Pregnancy during accurate hormonal contraceptive use

          -  Known or suspected breast cancer or a history of breast cancer

          -  Clinically significant abnormalities of the uterus and/or ovaries detected by
             examination and/or ultrasound (non-physiological ovarian mass or significant uterine
             pathology).

          -  A cervical smear with clinically relevant abnormal cytology within one year before
             study start.

          -  Previous use of depot progestogen preparations in the last 6 months.

          -  Contraindications for contraceptive steroids:

               -  a history of, or existing thromboembolic, cardiovascular or cerebrovascular
                  disorder

               -  a history of, or existing conditions predisposing to, or being prodromi of, a
                  thrombosis

               -  a known defect in the blood coagulation system (e.g. deficiencies in AT-III,
                  protein C, S, and APC resistance)

               -  heterozygous for a mutation in coagulation factor II and/or positive for factor V
                  Leiden

               -  the presence of a severe or more than one risk factor for vascular disease (e.g.
                  dyslipoproteinaemia; diabetes mellitus; hyperhomocysteinaemia; systemic lupus
                  erythematosus; chronic inflammatory bowel disease; antiphospholipid antibodies;
                  smoking; venous thromboembolism in sibling or parent below the age of 50, or
                  arterial disease in sibling or parent below the age of 35; within 2 weeks after
                  full remobilisation following surgery)

               -  hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood
                  pressure >90 mmHg

               -  disturbance of liver function: e.g. cholestatic jaundice, a history of jaundice
                  of pregnancy or jaundice due to previous oestrogen use, Rotor syndrome and
                  Dubin-Johnson syndrome

               -  known or suspected hormone-dependent tumours or endometrial hyperplasia

               -  undiagnosed vaginal bleeding

               -  porphyria

               -  a history during pregnancy or previous hormone-use of severe pruritus, herpes
                  gestationis or deterioration of otosclerosis

          -  Use of one or more of the following medications:

               -  sex steroids other than the medication of study

               -  use at present or within 2 months before start study medication:

               -  hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate,
                  troglitazone, felbamate, rifampicin, rifabutin, griseofulvin and St. John's wort
                  (Hypericum perforatum)

          -  Status post-partum or post-abortion within a period of 2 months before study start

          -  Administration of investigational drugs within 3 months before start study medication

          -  A history of (within 12 months) alcohol or drug abuse

          -  A known hypersensitivity for one of the components of the study medication (eg
             arachisoil and lactosis)