anticonceptie birth control contraception
Conditions
Interventions
Group study drug or placebo
1 0,1 mg
2 0,3 mg
3 1,0 mg
4 3,0 mg
5 9,0 mg
6 20 mg
Dosis can be adapted based on the obtained interim study results.
Sponsors
Akzo Nobel (Organon)Orion Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy sterilized females with normal ovulatory cycles (i.e. a mean cycle length between 24 and 35 days and an intra-individual variation of plus or minus 3 days, but never outside the 24-35 days range.) - Age between 18-50 years inclusive at the time of the first dosing administration. - BMI 18.0-30.0 kg/m2 (extremes included). - Good physical and mental health - Ability and willingness to sign the Informed Consent Form prior to screening evaluations.
Exclusion criteria
Exclusion criteria: • Contradictions for contraceptive steriods; • History of trombosis or an ilness related to trombosis; • an elevated risk of getting trombosis; • History of drugs and/or alcohol abuse; • Surgary within the last 3 months; • use of medication within 14 days prior to study start (exeption of ibuprofen); • if you participated in another trial within 3 months before the start of this study; • if you donated blood within 3 months before the start of the study; • if you are hepatitis B, C or HIV positive; • if you are not suitable according to the principal investigator to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety tolerability pharmacokinetics pharmacodynamics effect on ovulation | — |
Countries
Netherlands
Outcome results
None listed