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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00702585

Collaborator

(none)

Enrollment

Arms

14.5

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Org 36286 Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Oct 15, 2002

Actual Study Completion Date :

Oct 15, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Org 36286 7.5 µg 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.	Drug: Org 36286 Org 36286 single-dose subcutaneous injection Other Names: Corifollitropin alpha
Experimental: Org 36286 15 µg 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.	Drug: Org 36286 Org 36286 single-dose subcutaneous injection Other Names: Corifollitropin alpha
Experimental: Org 36286 30 µg 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.	Drug: Org 36286 Org 36286 single-dose subcutaneous injection Other Names: Corifollitropin alpha
Experimental: Org 36286 60 µg 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.	Drug: Org 36286 Org 36286 single-dose subcutaneous injection Other Names: Corifollitropin alpha
Placebo Comparator: 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.	Drug: Placebo Placebo to Org 36286 as a single-dose subcutaneous injection

Outcome Measures

Primary Outcome Measures

Participant Ovulation Rate in Monofollicular Cycles [Up to 2 Weeks Following LH Peak]

Secondary Outcome Measures

Participant Overall Ovulation Rate [Up to 2 Weeks Following LH Pek]
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 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]
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]
Participant Serum LH Level [Up to Day 21]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts 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.