A phase I, mono-center, randomized, placebo and comparator controlled, single blind, rising dose, clinical study to determine single dose pharmacokinetics, pharmacodynamics, safety and tolerability of four doses of FSH-GEX* according to adaptive design (25, 75, 150 and 300 IU) administered subcutaneously in healthy pituitary-suppressed female volunteers

A phase I, mono-center, randomized, placebo and comparator controlled, single blind, rising dose, clinical study to determine single dose pharmacokinetics, pharmacodynamics, safety and tolerability of four doses of FSH-GEX* according to adaptive design (25, 75, 150 and 300 IU) administered subcutaneously in healthy pituitary-suppressed female volunteers - GEXGP24101

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36196

Enrollment

Registered

2011-04-20

Start date

2011-04-08

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Infertility

Interventions

The study will start with a screening visit. During the screening visit standard medical assessments including safety laboratory tests (blood draw, urine collection), an alcohol breath test, urine d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy female subjects

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at screening

Design outcomes

Primary

Measure	Time frame
- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection - To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising dose administration by subcutaneous injection.	—

Secondary

Measure	Time frame
- To assess the pharmacodynamic effect of test compound following single rising dose administration by subcutaneous injection as determined by Estradiol (E2) and inhibin B concentrations and ovarian follicle size, as determined by transvaginal ultrasonography (TVUS)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)