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

NCT00702585 | Completed Phase 2 DMC

• 2 other identifiers: P0701638805
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Keywords

Ovulation Induction; Pharmacological effects of drugs; Hormones; Hormone substitutes and Hormone Antagonists; Pharmacological Actions; Randomized; Multi-center; Multi-national

Outcome Measures

Primary Outcomes (1)

• Participant Ovulation Rate in Monofollicular Cycles

  Up to 2 Weeks Following LH Peak

Secondary Outcomes (12)

• 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

Study Arms (5)

Org 36286 7.5 µg

EXPERIMENTAL

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 15 µg

EXPERIMENTAL

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 30 µg

EXPERIMENTAL

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 60 µg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Org 36286 DRUG

Org 36286 single-dose subcutaneous injection

Also known as: Corifollitropin alpha

Org 36286 15 µg; Org 36286 30 µg; Org 36286 60 µg; Org 36286 7.5 µg

Placebo DRUG

Placebo to Org 36286 as a single-dose subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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 World Health Organization group II anovulatory infertility. J Clin Endocrinol Metab. 2004 Dec;89(12):6297-304. doi: 10.1210/jc.2004-0668.

  PMID: 15579793 RESULT

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: August 1, 2001
• Primary Completion: October 15, 2002
• Study Completion: October 15, 2002
• Last Updated: August 15, 2024

Record last verified: 2022-02