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)

• Status: Terminated
• Trial end date: 2008-05-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Chorionic Gonadotropin; Follicle Stimulating Hormone; Hormones; Progestins

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