Trials / Completed
CompletedNCT03564509
A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-range Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation in a Long GnRH Agonist Protocol
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 620 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 30 Years – 42 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS) with follitropin delta in a long gonadotropin releasing hormone (GnRH) agonist protocol. Furthermore, the study intends: * To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in a long GnRH agonist protocol. * To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol. * To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FE 999302 (1 μg) and follitropin delta | Daily dose of 1 μg of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualized follitropin delta dose. |
| DRUG | FE 999302 (2 μg) and follitropin delta | Daily dose of 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. |
| DRUG | FE 999302 (4 μg) and follitropin delta | Daily dose of 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. |
| DRUG | FE 999302 (8 μg) and follitropin delta | Daily dose of 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. |
| DRUG | FE 999302 (12 μg) and follitropin delta | Daily dose of 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. |
| OTHER | Placebo and follitropin delta | Daily dose of placebo; individualized follitropin delta dose. |
Timeline
- Start date
- 2018-05-14
- Primary completion
- 2019-10-21
- Completion
- 2020-01-08
- First posted
- 2018-06-21
- Last updated
- 2023-08-31
Locations
20 sites across 5 countries: Belgium, Czechia, Denmark, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03564509. Inclusion in this directory is not an endorsement.