Infertility Clinical Trial
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
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | October 15, 2002 |
Est. primary completion date | October 15, 2002 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Organon and Co |
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 Wo — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant Ovulation Rate in Monofollicular Cycles | Up to 2 Weeks Following LH Peak | ||
Secondary | Participant Overall Ovulation Rate | Up to 2 Weeks Following LH Pek | ||
Secondary | Number of Participants With Cancellation of Menstrual Cycle | Up to Day 21 | ||
Secondary | Participant Follicle Size | Up to Day 21 | ||
Secondary | Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies | Up to 10 Weeks Following Ovulation | ||
Secondary | Number of Participants Experiencing Serious Adverse Events (SAEs) | Up to 10 Weeks Following Ovulation | ||
Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 3 Weeks Following Ovulation | ||
Secondary | Number of Participants With Clinically Significant Changes in Vital Signs | Up to 3 Weeks Followiing Ovulation | ||
Secondary | Number of Participants With Antibodies to Org 36286 | Up to 3 Weeks Following Ovulation | ||
Secondary | Participant Serum Follicle Stimulating Hormone (FSH) Level | Up to Day 21 | ||
Secondary | Participant Serum LH Level | Up to Day 21 | ||
Secondary | Participant Inhibin-B, E2, and P Serum Concentration | Up to Day 21 | ||
Secondary | Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS) | Up to 2 Weeks Following LH Peak |
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