A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)

A Phase II, Randomized, Controlled, Open-label, Feasibility Trial to Evaluate if a Single or Repeated Dose of Org 36286 (Corifollitropin Alfa) Followed by a Low Daily Dose of Either hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility

The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.

This trial will include two separate stages (Ia+Ib and II).

Stage Ia will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recFSH provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage Ib will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose hCG provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage II is open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose FSH (n=20) or hCG (n=20) provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Inclusion Criteria:

• Oligomenorrhea (average cycle length ≥35 days and <6 months)
• Amenorrhea (average cycle length ≥6 months)
• Body Mass Index ≥18 and ≤30 kg/m^2
• Normal serum FSH levels and normal estradiol levels at screening
• Progestagen induced withdrawal bleeding
• Age ≥18 years and ≤39 years at the time of signing informed consent
• Willing and able to sign informed consent

Exclusion Criteria:

• History of or current ovarian cysts or enlarged ovaries not related to polycystic ovarian syndrome (PCOS)
• History of or current tumors of the ovary, breast, uterus, pituitary or

hypothalamus

• Less than 2 ovaries
• Undiagnosed vaginal bleeding
• Any ovarian and/or abdominal abnormality interfering with ultrasound

examination

• Malformations of the sexual organs incompatible with pregnancy
• Pregnancy or lactation
• Abnormal serum endocrinology levels based on screening sample
• Any clinically relevant abnormal laboratory value based on screening sample
• Alcohol or drug abuse within the 12 months preceding signing of informed consent
• Hypersensitivity to any of the substances in corifollitropin alfa
• Hypersensitivity to hCG/ Puregon® or any of its components
• Previous use of corifollitropin alfa
• Use of any investigational drug during 90 days before screening