Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (Study 38805)(COMPLETED) - Full Text View

Purpose

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	Intervention	Phase
Infertility	Drug: Corifollitropin Alfa Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Ovulation rate in monofollicular cycles [ Time Frame: One Cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall ovulation rate [ Time Frame: End of Trial ] [ Designated as safety issue: No ]
Cycle Cancellation [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
Serum FSH, LH, inhibin-B, E2, and P concentrations [ Time Frame: From the day of administration of trial medication to either the day of LH peak or Day 21 ] [ Designated as safety issue: No ]
The number of follicles 8-9 mm, 10-11 mm, 12-14 mm, 15-17 mm and = 18 mm [ Time Frame: Measured from the day of administration of trial medication to either the Day of LH peak or Day 21 ] [ Designated as safety issue: No ]
Miscarriages and biochemical, ectopic, clinical, vital, single and multiple ongoing pregnancies [ Time Frame: When/if event occurs ] [ Designated as safety issue: No ]
Pharmacokinetics-pharmacodynamics of Org 36286 [ Time Frame: Day 1 (just prior to injection of Org 36286), 3, 5 and 7 ] [ Designated as safety issue: No ]
Serious Adverse Events [ Time Frame: Throughout trial ] [ Designated as safety issue: Yes ]
Laboratory parameters (hematology, biochemistry, urinalysis) [ Time Frame: Screening and at follow-up (third week after ovulation) ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Screening and at follow-up (third week after ovulation) ] [ Designated as safety issue: Yes ]
Antibodies against Org 36286 [ Time Frame: Pre-treatment and at follow-up (third week after ovulation) ] [ Designated as safety issue: Yes ]

Enrollment:	55
Study Start Date:	August 2001
Study Completion Date:	October 2002
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 7.5 µg Org 36286 (corifollitropin alfa)	Drug: Corifollitropin Alfa single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later Other Name: Org 36286
Experimental: Arm 2 15 µg Org 36286 (corifollitropin alfa)	Drug: Corifollitropin Alfa single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later Other Name: Org 36286
Experimental: Arm 3 30 µg Org 36286 (corifollitropin alfa)	Drug: Corifollitropin Alfa single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later Other Name: Org 36286
Experimental: Arm 4 60 µg Org 36286 (corifollitropin alfa)	Drug: Corifollitropin Alfa single subcutaneous injection of 7.5, 15, 30, or 60 ug Org 36286. The Org 36286 injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later Other Name: Org 36286
Placebo Comparator: Arm 5 Placebo	Drug: Placebo single subcutaneous injection of placebo. The placebo injection was given on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later

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

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Wish to conceive;
Oligmenorrhea (cycle length >=41 days) or amenorrhea (no menstrual cycle for >6 months);
At least 18 and at most 39 years of age at the time of screening;
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;
Willing to give written informed consent.

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00702585 History of Changes
Other Study ID Numbers:	38805
Study First Received:	June 18, 2008
Last Updated:	October 2, 2009
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Schering-Plough:

Ovulation Induction
Pharmacological effects of drugs
Hormones
Hormone substitutes and Hormone Antagonists

Pharmacological Actions
Randomized
Multi-center
Multi-national

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013