Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)

• Status: Completed
• Trial end date: 2002-10-15
• Target enrollment: 0
• Participant gender: Female

Summary

The objectives of this trial were to investigate the feasibility and the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility and to assess the safety (including the absence of antibody formation) of Org 36286.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Wish to conceive;

• Oligomenorrhea (cycle length >=41 days) or amenorrhea (no menstrual cycle for >6 months);

• Body Mass Index (BMI) >=18 and <=32 kg/m^2;

• Serum FSH levels within normal limits (1-10 IU/L);

• Normal serum prolactin and thyroid stimulating hormone (TSH) levels;

• Progestagen induced withdrawal bleeding or spontaneous menstrual bleeding;

Exclusion Criteria:

• Tumours of the ovary, breast, uterus, pituitary or hypothalamus;

• Pregnancy or lactation;

• Undiagnosed vaginal bleeding;

• Ovarian cysts or enlarged ovaries not related to polycystic ovarian disease (PCOD);

• Any ovarian and/or abdominal abnormality interfering with ultrasound examination;

• Malformations of the sexual organs incompatible with pregnancy;

• Clomiphene resistance with documented anovulation (treated with 150 mg clomiphene for five days and no ovulation);

• Treatment with metformin, gonadotropins, or GnRH analogs within 90 days prior to the start of Org 36286 treatment;

• Treatment with clomiphene citrate within 42 days prior to the start of Org 36286 treatment;

• Alcohol or drug abuse within the 12 months preceding signing of informed consent;

• Any clinically relevant abnormal laboratory value;

• Hypersensitivity to any of the substances in Org 36286;

• Hypersensitivity to Orgalutran® or any of its components;

• Use of any investigational drugs during 90 days before screening or previous participation in this trial.