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)

NCT00697255 | Terminated Phase 2 Results

• 4 other identifiers: P056932006-000705-30107010MK-8962-002
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovulation Induction

Keywords

Pharmacological effects of drugs; Hormones; Hormone Substitutes and Hormone Antagonists; Pharmacological Actions; Monofollicular growth; Randomized; Open-label; Active-controlled

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Monofollicular Response (Monofollicular Rate)

  The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.

  At day of bolus injection of hCG (up to 20 days)

Secondary Outcomes (5)

• Percentage of Participants With Ovulation (Ovulation Rate)

  8 days after bolus injection of hCG (up to 28 days)

• Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)

  8 days after bolus injection of hCG (up to 28 days)

• Percentage of Participants Who Cancelled Treatment (Cancellation Rate)

  Up to 3 weeks after bolus injection of hCG (up to 41 days)

• Number of Participants With Pregnancy

  At least 10 weeks after bolus injection of hCG (up to 13 weeks)

• Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)

  During In-Treatment Period (up to 14 weeks after first corifollitropin injection)

Study Arms (2)

corifollitropin alfa + recFSH

EXPERIMENTAL

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.

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

corifollitropin alfa + hCG

EXPERIMENTAL

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.

Drug: corifollitropin alfa; Biological: human Chorion Gonadotropin (hCG); Biological: hCG Bolus injection

Interventions

human Chorion Gonadotropin (hCG) 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.

Also known as: Pregnyl®

corifollitropin alfa + hCG

corifollitropin alfa 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).

Also known as: Org 36286, SCH 900962, MK-8962

corifollitropin alfa + hCG; corifollitropin alfa + recFSH

recombinant Follicle Stimulating Hormone (recFSH) 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.

Also known as: Puregon®

corifollitropin alfa + recFSH

hCG Bolus injection 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.

Also known as: Pregnyl®

corifollitropin alfa + hCG; corifollitropin alfa + recFSH

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; Glycoprotein Hormones, alpha Subunit; follitropin beta; Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: May 15, 2007
• Primary Completion: April 3, 2008
• Study Completion: May 15, 2008
• Last Updated: June 17, 2024
• Results First Posted: June 9, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share