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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Org 36286
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Ovulation Induction, Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Org 36286 7.5 µg

    Org 36286 15 µg

    Org 36286 30 µg

    Org 36286 60 µg

    Placebo

    Arm 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.

    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 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 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 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.

    Outcomes

    Primary Outcome Measures

    Participant Ovulation Rate in Monofollicular Cycles

    Secondary Outcome Measures

    Participant Overall Ovulation Rate
    Number of Participants With Cancellation of Menstrual Cycle
    Participant Follicle Size
    Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies
    Number of Participants Experiencing Serious Adverse Events (SAEs)
    Number of Participants With Clinically Significant Laboratory Abnormalities
    Number of Participants With Clinically Significant Changes in Vital Signs
    Number of Participants With Antibodies to Org 36286
    Participant Serum Follicle Stimulating Hormone (FSH) Level
    Participant Serum LH Level
    Participant Inhibin-B, E2, and P Serum Concentration
    Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)

    Full Information

    First Posted
    June 18, 2008
    Last Updated
    February 1, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00702585
    Brief Title
    Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2001 (Actual)
    Primary Completion Date
    October 15, 2002 (Actual)
    Study Completion Date
    October 15, 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    Ovulation Induction, Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Org 36286 7.5 µg
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Org 36286 15 µg
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Org 36286 30 µg
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Org 36286 60 µg
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Org 36286
    Other Intervention Name(s)
    Corifollitropin alpha
    Intervention Description
    Org 36286 single-dose subcutaneous injection
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to Org 36286 as a single-dose subcutaneous injection
    Primary Outcome Measure Information:
    Title
    Participant Ovulation Rate in Monofollicular Cycles
    Time Frame
    Up to 2 Weeks Following LH Peak
    Secondary Outcome Measure Information:
    Title
    Participant Overall Ovulation Rate
    Time Frame
    Up to 2 Weeks Following LH Pek
    Title
    Number of Participants With Cancellation of Menstrual Cycle
    Time Frame
    Up to Day 21
    Title
    Participant Follicle Size
    Time Frame
    Up to Day 21
    Title
    Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies
    Time Frame
    Up to 10 Weeks Following Ovulation
    Title
    Number of Participants Experiencing Serious Adverse Events (SAEs)
    Time Frame
    Up to 10 Weeks Following Ovulation
    Title
    Number of Participants With Clinically Significant Laboratory Abnormalities
    Time Frame
    Up to 3 Weeks Following Ovulation
    Title
    Number of Participants With Clinically Significant Changes in Vital Signs
    Time Frame
    Up to 3 Weeks Followiing Ovulation
    Title
    Number of Participants With Antibodies to Org 36286
    Time Frame
    Up to 3 Weeks Following Ovulation
    Title
    Participant Serum Follicle Stimulating Hormone (FSH) Level
    Time Frame
    Up to Day 21
    Title
    Participant Serum LH Level
    Time Frame
    Up to Day 21
    Title
    Participant Inhibin-B, E2, and P Serum Concentration
    Time Frame
    Up to Day 21
    Title
    Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)
    Time Frame
    Up to 2 Weeks Following LH Peak

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15579793
    Citation
    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.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

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

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