Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
- Registration Number
- NCT00702585
- Lead Sponsor
- Organon and Co
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 55
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Org 36286 7.5 µg Org 36286 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 Org 36286 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 Org 36286 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 Org 36286 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 Placebo 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.
- Primary Outcome Measures
Name Time Method Participant Ovulation Rate in Monofollicular Cycles Up to 2 Weeks Following LH Peak
- Secondary Outcome Measures
Name Time Method Participant Overall Ovulation Rate Up to 2 Weeks Following LH Pek Participant Serum LH Level Up to Day 21 Number of Participants With Cancellation of Menstrual Cycle Up to Day 21 Participant Follicle Size Up to Day 21 Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies Up to 10 Weeks Following Ovulation Number of Participants Experiencing Serious Adverse Events (SAEs) Up to 10 Weeks Following Ovulation Number of Participants With Antibodies to Org 36286 Up to 3 Weeks Following Ovulation Participant Serum Follicle Stimulating Hormone (FSH) Level Up to Day 21 Number of Participants With Clinically Significant Laboratory Abnormalities Up to 3 Weeks Following Ovulation Number of Participants With Clinically Significant Changes in Vital Signs Up to 3 Weeks Followiing Ovulation Participant Inhibin-B, E2, and P Serum Concentration Up to Day 21 Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS) Up to 2 Weeks Following LH Peak