Clinical trial NCT00702585: Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Comparative Trial to Investigate the Optimal Dose of a Single Administration of Org 36286 (Corifollitropin Alfa) to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: Ovulation Induction
Pharmacological effects of drugs
Hormones
Hormone substitutes and Hormone Antagonists
Pharmacological Actions
Randomized
Multi-center
Multi-national
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Participant Ovulation Rate in Monofollicular Cycles
timeFrame: Up to 2 Weeks Following LH Peak
Secondary outcomes:
measure: Participant Overall Ovulation Rate
timeFrame: Up to 2 Weeks Following LH Pek
measure: Number of Participants With Cancellation of Menstrual Cycle
timeFrame: Up to Day 21
measure: Participant Follicle Size
timeFrame: Up to Day 21
measure: Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies
timeFrame: Up to 10 Weeks Following Ovulation
measure: Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: Up to 10 Weeks Following Ovulation
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Up to 3 Weeks Following Ovulation
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Up to 3 Weeks Followiing Ovulation
measure: Number of Participants With Antibodies to Org 36286
timeFrame: Up to 3 Weeks Following Ovulation
measure: Participant Serum Follicle Stimulating Hormone (FSH) Level
timeFrame: Up to Day 21
measure: Participant Serum LH Level
timeFrame: Up to Day 21
measure: Participant Inhibin-B, E2, and P Serum Concentration
timeFrame: Up to Day 21
measure: Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: Up to 2 Weeks Following LH Peak
Other outcomes:
Locations:
Study officials:
References:
citation: Balen AH, Mulders AG, Fauser BC, Schoot BC, Renier MA, Devroey P, Struijs MJ, Mannaerts BM. Pharmacodynamics of a single low dose of long-acting recombinant follicle-stimulating hormone (FSH-carboxy terminal peptide, corifollitropin alfa) in women with World Health Organization group II anovulatory infertility. J Clin Endocrinol Metab. 2004 Dec;89(12):6297-304. doi: 10.1210/jc.2004-0668.