Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
Infertility
About this trial
This is an interventional treatment trial for Infertility focused on measuring Ovulation Induction, Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Org 36286 7.5 µg
Org 36286 15 µg
Org 36286 30 µg
Org 36286 60 µg
Placebo
Org 36286 7.5 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Org 36286 15 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Org 36286 30 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Org 36286 60 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Placebo to Org 36286 administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.