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)

NCT ID: NCT00697255

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-15
• Study Completion Date: 2008-05-15

Brief Summary

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.

Detailed 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.

Conditions

Ovulation Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

corifollitropin alfa + recFSH

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.

Group Type: EXPERIMENTAL

corifollitropin alfa

Intervention Type: DRUG

SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg).

recombinant Follicle Stimulating Hormone (recFSH)

Intervention Type: BIOLOGICAL

Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.

hCG Bolus injection

Intervention Type: BIOLOGICAL

Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed.

corifollitropin alfa + hCG

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.

Group Type: EXPERIMENTAL

corifollitropin alfa

Intervention Type: DRUG

SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg).

human Chorion Gonadotropin (hCG)

Intervention Type: BIOLOGICAL

Daily injections of SC hCG (200 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.

hCG Bolus injection

Intervention Type: BIOLOGICAL

Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed.

Interventions

corifollitropin alfa

SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg).

Intervention Type: DRUG

recombinant Follicle Stimulating Hormone (recFSH)

Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.

Intervention Type: BIOLOGICAL

human Chorion Gonadotropin (hCG)

Daily injections of SC hCG (200 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.

Intervention Type: BIOLOGICAL

hCG Bolus injection

Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed.

Intervention Type: BIOLOGICAL

Other Intervention Names

Org 36286; SCH 900962; MK-8962; Puregon®; Pregnyl®; Pregnyl®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2006-000705-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

107010

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8962-002

Identifier Type: OTHER

Identifier Source: secondary_id

P05693

Identifier Type: -

Identifier Source: org_study_id