The objectives are:1. To investigate the tolerability and safety of Org 201745-0 following single dose oral administration of six (tentative) escalating doses.2. To investigate the single dose pharmacokinetics of Org 201745-0, speed of absorption…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anticonceptie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
safety
tolerability
pharmacokinetics
pharmacodynamics
effect on ovulation
Secondary outcome
NA
Background summary
Org 201745-0 is developed for use as female contraception suitable for once a
week administration
Study objective
The objectives are:
1. To investigate the tolerability and safety of Org 201745-0 following single
dose oral administration of six (tentative) escalating doses.
2. To investigate the single dose pharmacokinetics of Org 201745-0, speed of
absorption and secretion following single dose oral administration.
3. To investigate the pharmacodynamic effects of Org 201745-0 following single
dose oral administration and to explore and, if possible, identify the major
metabolites of Org 201745-0 in plasma and urine.
Study design
A maximum of 6 groups of 8 healthy female volunteers will participate in this
study. The study consists of a medical screening, 1 admission period of 4 days,
17 short visits and finally a follow up.
Intervention
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.
Study burden and risks
The volunteers are during the course of the studyunder continious medical care
of kendle staff. The starting dose is low and determined based on pre-clinical
data. Furthermore, if needed the dosing schedule can be adapted.
molenstraat 110
5340 BH
Nederland
molenstraat 110
5340 BH
Nederland
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001111-37-NL |
| CCMO | NL17070.040.07 |