Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)

Organon

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: Org 36286; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00702585

38805

P07016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 5 patient groups, including a placebo group

Org 36286 7.5 µg

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Org 36286 15 µg

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Org 36286 30 µg

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Org 36286 60 µg

Experimental group

Description:

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.

Treatment:

Drug: Org 36286

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo