- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To assess the safety and tolerability of FSH-GEX* following multiple dose
administration by subcutaneous injection
Secondary outcome
- 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)
Background summary
The aim of the current study is to investigate the safety and (local)
tolerability of FSH-GEX* following multiple dose administration by
subcutaneous injection in healthy pituitary-suppressed female volunteers, in
comparison with two marketed products
Study objective
- To assess the safety and tolerability of FSH-GEX* following multiple dose
administration by subcutaneous injection
- 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)
Study design
This is a phase I, single-blind, placebo and comparator controlled, randomized,
multiple dose study in healthy adult female volunteers at 3 different dose
levels. There will be five cohorts: cohorts 1,2,3 and 5 consists of 12 subjects
and cohort 4 consists of 8 subjects. In cohort 1, 10 subjects will receive
FSH-GEX* and 2 subjects will receive placebo. In cohort 2, 12 subjects will
receive either 150 IU Gonal-f® or 150 IU Bravelle®. In cohort 3, 10 subjects
will receive FSH-GEX* and 2 subjects will receive placebo. In cohort 4, 8
subjects will receive will receive either 150 IU Gonal-f® or 150 IU Bravelle®.
In cohort 5, 10 subjects will receive FSH-GEX* and 2 subjects will receive
placebo. Each subject will receive maximally 7 daily doses of FSH-GEX* or
Gonal-f® or Bravelle® or placebo.
Intervention
n.a.
Study burden and risks
The side effects of the active ingredient of FSH-GEX* is expected to be the
same as the side effects reported for the comparator Gonal-F® and Bravelle®.
The most common side effects reported for both Gonal-f® and Bravelle® are:
ovarian cysts, headache and local reaction at the injection site (pain,
redness, bruising, swelling and/or irritation). Following multiple-dose
treatment with Gonal-f® a condition called OHSS (Ovarian Hyper Stimulation
Syndrome) can occur. The syndrome is characterized by large ovarian cysts.
First symptoms are pain in the lower abdominal region, possibly in combination
with nausea, vomiting and weight gain. In rare cases of OHSS, serious
complications may occur.
Robert-Rössle-Str. 10
13125, Berlin
DE
Robert-Rössle-Str. 10
13125, Berlin
DE
Listed location countries
Age
Inclusion criteria
Healthy female subjects
Exclusion criteria
Clinically significant abnormalities at screening
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004600-38-NL |
| CCMO | NL38268.056.11 |