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.

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. - BE study of freeze-dried Luveris vs Luveris in pre-filled pen

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37820

Enrollment

Registered

2012-08-09

Start date

2012-10-01

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

vrouwelijke ovruchtbaarheid female infertility

Interventions

Test treatment: a single dose of four clicks with the fertility pen of 150 IU Luveris each, administered immediately after each other Reference treatment: a single dose of four subcutaneous inject

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma LH concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, trans vaginal ultrasound, local tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)