An open-label, randomized, two-period, two-sequence crossover, single-center trial to assess the bioequivalence of a single dose of 600 IU of freeze-dried r-hLH (Luveris®) versus a single 600 IU dose of the liquid formulation of Luveris® in the Pre-Filled Pen, administered subcutaneously (SC) in pituitary suppressed healthy premenopausal female subjects.

Completed

• Conditions: vrouwelijke ovruchtbaarheid; female infertility; pituitary hormone deficiency

• Registration Number: NL-OMON37820
• Lead Sponsor: Merck Sharp & Dohme (MSD)

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: 54

Inclusion Criteria

healthy female subjects
18-40 yrs, inclusive
BMI: 18.5-30.0 kg/m2, inclusive, and weigh more than 50 kg
non-smoking or smoking less then 5 cigarettes per day

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters 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>Pharmacokinetics: plasma LH concentrations, pharmacokinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination, trans vaginal ultrasound, local tolerability</p><br>

Secondary Outcome Measures

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