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

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 - SCH 900479 FIM study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34172

Enrollment

Registered

2010-05-17

Start date

2010-10-05

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hot flashes Menopausal symptoms

Interventions

Active substance: SCH 900479,17-* estradiol, Provera®

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
- Pharmacodynamics - Pharmacokinetics - Safety	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)