A phase I, mono-center, placebo and comparator controlled, single-blind, randomized, parallel group, clinical study to determine multiple dose safety, tolerability, pharmacokinetics, and pharmacodynamics of FSH-GEX* administered subcutaneously in healthy pituitary-suppressed female volunteers

A phase I, mono-center, placebo and comparator controlled, single-blind, randomized, parallel group, clinical study to determine multiple dose safety, tolerability, pharmacokinetics, and pharmacodynamics of FSH-GEX* administered subcutaneously in healthy pituitary-suppressed female volunteers - GEXGP24102

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35651

Enrollment

Registered

2011-10-07

Start date

2011-10-13

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

Infertility

Interventions

n.a.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy female subjects

Exclusion criteria

Exclusion criteria: Clinically significant abnormalities at screening

Design outcomes

Primary

Measure	Time frame
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection	—

Secondary

Measure	Time frame
- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection - To assess the pharmacodynamic effect of FSH-GEX* following multiple dose administration by subcutaneous injection as determined by Luteinizing Hormone (LH), Estradiol (E2) and Inhibin-B concentrations and ovarian follicle size, as determined by transvaginal ultrasonography (TVUS)	—

Measure

Time frame

- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection - To assess the pharmacodynamic effect of FSH-GEX* following multiple dose administration by subcutaneous injection as determined by Luteinizing Hormone (LH), 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)