A Combined Escalating Single Oral Dose and Multiple Oral Dose Trial investigating Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SCH 900479 in Healthy Postmenopausal Female Subjects

Completed

• Conditions: hot flashes; Menopausal symptoms; 10074469

• Registration Number: NL-OMON34172
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

- Age 45-65 years old
- BMI: 18-32
- Post-menopausal for at least one year or at least 6 months without menstrual cycle and FH levels higher than 40mLU/mL
- Non-smoking or did not smoke in the last 3 months prior screening

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study or in case of donating more than 1 liter of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pharmacodynamics<br /><br>- Pharmacokinetics<br /><br>- Safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>