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)

Organon

Status and phase: Terminated; Phase 2

Conditions: Ovulation Induction

Treatments: Biological: human Chorion Gonadotropin (hCG); Biological: hCG Bolus injection; Drug: corifollitropin alfa; Biological: recombinant Follicle Stimulating Hormone (recFSH)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00697255

2006-000705-30 (EudraCT Number)

P05693

MK-8962-002 (Other Identifier)

107010 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

corifollitropin alfa + recFSH

Experimental group

Description:

Eligible participants will receive a subcutaneous (SC) injection of corifollitropin alfa (Stage 1a: 15mcg, Stage Ib/II: 30 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient, the participant will receive a second or third dose of corifollitropin alfa (Stage 1a: 15 mcg, Stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm, the participant will start daily SC injections with FSH (Stage 1A: 50 IU, Stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed.

Treatment:

Biological: recombinant Follicle Stimulating Hormone (recFSH)

Drug: corifollitropin alfa

Biological: hCG Bolus injection

corifollitropin alfa + hCG

Experimental group

Description:

Eligible participants will receive a SC injection of corifollitropin alfa (Stage Ia:15 mcg, Stage Ib/II: 30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the participant will receive a second or third dose of corifollitropin alfa (Stage IA: 15 mcg, stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm the participant will start daily SC injections with hCG (Stage Ib/II: 200 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed.

Treatment:

Drug: corifollitropin alfa

Biological: hCG Bolus injection

Biological: human Chorion Gonadotropin (hCG)