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.
This was a phase II, randomized, double-blind, placebo controlled, comparative trial to investigate the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility. Treatment injection was given on Day 1-3 after the onset of a spontaneous or progestagen induced withdrawal bleeding. After injection, ultrasound monitoring and sampling for serum hormones were done on treatment Days 3, 5, and daily from Day 7 to 21 or until a urinary luteinizing hormone (LH) peak was detected. From treatment Day 7 the urinary LH response was assessed to detect the preovulatory LH peak. In case of hyperstimulation, production of endogenous gonadotropins could be suppressed by giving daily injections of GnRH antagonist. Post-treatment assessments were done in the third week after the urinary LH peak. If no LH peak was detected, posttreatment assessments were performed four to five weeks after Org 36286 or placebo injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
Participant Ovulation Rate in Monofollicular Cycles
Time frame: Up to 2 Weeks Following LH Peak
Participant Overall Ovulation Rate
Time frame: Up to 2 Weeks Following LH Pek
Number of Participants With Cancellation of Menstrual Cycle
Time frame: Up to Day 21
Participant Follicle Size
Time frame: Up to Day 21
Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies
Time frame: Up to 10 Weeks Following Ovulation
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 10 Weeks Following Ovulation
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to 3 Weeks Following Ovulation
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to 3 Weeks Followiing Ovulation
Number of Participants With Antibodies to Org 36286
Time frame: Up to 3 Weeks Following Ovulation
Participant Serum Follicle Stimulating Hormone (FSH) Level
Time frame: Up to Day 21
Participant Serum LH Level
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Time frame: Up to Day 21
Participant Inhibin-B, E2, and P Serum Concentration
Time frame: Up to Day 21
Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: Up to 2 Weeks Following LH Peak