An escalating single oral dose trial investigating the safety, tolerance, pharmacokinetics and pharmacodynamics of orally administered Org 201745-0 in healthy sterilized women with normal ovulatory cycles

Completed

• Conditions: anticonceptie; birth control; contraception

• Registration Number: NL-OMON30881
• Lead Sponsor: Akzo Nobel (Organon)Orion Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>safety<br /><br>tolerability<br /><br>pharmacokinetics<br /><br>pharmacodynamics<br /><br>effect on ovulation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>