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. (RAINBOW)

Ferring

Status and phase: Completed; Phase 2

Conditions: Controlled Ovarian Stimulation

Treatments: Drug: FE 999302 (1 μg) and follitropin delta; Drug: FE 999302 (2 μg) and follitropin delta; Drug: FE 999302 (4 μg) and follitropin delta; Drug: FE 999302 (8 μg) and follitropin delta; Drug: FE 999302 (12 μg) and follitropin delta; Other: Placebo and follitropin delta

Study type: Interventional

Funder types: Industry

Identifiers

NCT03564509

2017-003810-13 (EudraCT Number)

000289

Details and patient eligibility

About

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.

Enrollment: 620 patients

Sex: Female

Ages: 30 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent documents signed prior to screening evaluations.
• In good physical and mental health as judged by the investigator.
• Anti-Müllerian hormone (AMH) levels at screening of 5.0-35.0 pmol/L (as measured by Elecsys® AMH Plus Immunoassay [Roche Diagnostics] at central laboratory).
• Pre-menopausal women between the ages of 30 and 42 years. The subjects must be at least 30 years (including the 30th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent.
• Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation and/or intracytoplasmic sperm injection using fresh or frozen ejaculated sperm from male partner or sperm donor.
• Infertility for at least 1 year before screening for subjects less than 35 years or for at least 6 months for subjects greater than equal to (≥)35 years (not applicable in case of tubal or severe male factor infertility).

Exclusion criteria

• Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996).
• One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound after down-regulation prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation).
• Pregnancy (negative pregnancy tests must be documented at screening and prior to start of down-regulation) or contraindication to pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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620 participants in 6 patient groups, including a placebo group

FE 999302 (1 μg) and follitropin delta

Experimental group

Treatment:

Drug: FE 999302 (1 μg) and follitropin delta

FE 999302 (2 μg) and follitropin delta

Experimental group

Treatment:

Drug: FE 999302 (2 μg) and follitropin delta

FE 999302 (4 μg) and follitropin delta

Experimental group

Treatment:

Drug: FE 999302 (4 μg) and follitropin delta

FE 999302 (8 μg) and follitropin delta

Experimental group

Treatment:

Drug: FE 999302 (8 μg) and follitropin delta

FE 999302 (12 μg) and follitropin delta

Experimental group

Treatment:

Drug: FE 999302 (12 μg) and follitropin delta

Placebo and follitropin delta

Placebo Comparator group

Treatment:

Other: Placebo and follitropin delta