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A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Follitropin alfa injected by Pen device
Recombinant Human Choriogonadotropin (r-hCG)
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Oligoanovulatory infertility, Follitropin alfa, Pen device, Gonal-f®, Recombinant Human Choriogonadotropin (r-hCG), Ovidrel®

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Infertile woman wishing to conceive who has had at least 1 previous cycle of treatment with injectable gonadotropins within the past 6 months, excluding treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device, whose physician has recommended that she undergo ovulation induction. This inclusion criterion is modified to include subjects who had previous treatment with any gonadotropin multi-dose formulation in vials, excluding those gonadotropins administered by a Pen device Premenopausal and aged 18-40 years, inclusive Ovulatory dysfunction as defined by any of the following (a) usual cycle length less than (<) 21 or greater than (>) 35 days with at least 6 menses per year (b) usual cycle length > 35 days with less than 6 menses per year. Subjects in this group must have a positive response to a progesterone challenge within the past 6 months or during the screening period Spontaneous menses or a positive response to progestin withdrawal within 6 months of the start of gonadotropin therapy or positive response to clomiphene citrate withdrawal at least 30 days prior to start of gonadotropin therapy is acceptable to demonstrate induced menses Normal Papanicolaou (PAP) smear within 6 months prior to initial visit Male partner with an acceptable semen analysis within 6 months prior to study entry, according to the standard practice at the clinic, for ovulation induction. Use of donor sperm is acceptable Body mass index (BMI) less than 35.0 kilogram per square meter (kg/m^2). BMI = Body Weight / Height x Height (BMI is equal to body weight [kilogram {kg}] divided by Height * Height [square meter {m^2}]) Patency and apparent normality of at least 1 fallopian tube with an ipsilateral functional ovary, as documented by an hysterosonogram or hysterosalpingography (HSG) within 3 years prior to study entry Local laboratory screening results demonstrating the following, within the past year: (a) prolactin within normal limits (b) Follicle stimulating hormone (FSH) within the normal limit for the early follicular phase at the local laboratory (c) thyroid stimulating hormone (TSH) within normal limits. Subjects with low TSH levels who were receiving replacement therapy could be enrolled at the discretion of the Investigator Been willing and able to comply with the protocol for the duration of the study Voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure not part of normal medical care, with the understanding that consent could be withdrawn by the subject at any time without prejudice to their future medical care. The male partner must also have provided a written subject authorization under HIPAA Exclusion Criteria: Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening Previous treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device in the past 6 months Any significant allergic disease, which in the opinion of the Investigator could interfere with study treatment Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus Prior severe Ovarian Hyperstimulation Syndrome (OHSS) Significant allergic response to gonadotropin preparations Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term Clinically significant abnormal findings evident on a transvaginal pelvic ultrasound performed within 2 cycles (maximum 90 days) of study entry Poor response in a prior gonadotropin stimulation cycle, defined as an estradiol level < 100 pg/mL per mature follicle (>=16 mm mean diameter) Prior excessive response to gonadotropin stimulation as defined by development of >3 mature follicles at a treatment dose of 75 IU FSH Treatment with gonadotropins, clomiphene citrate, insulin-sensitizing agents (e.g., metformin, Avandia®) or Gonadotropin Releasing Hormone (GnRH) analogs within 1 month prior to study entry Hypothyroidism (untreated). Subjects with low Thyroid Stimulating Hormone (TSH) levels who were receiving replacement therapy (e.g., Synthroid) could be enrolled at the discretion of the Investigator if local laboratory results demonstrated satisfactory thyroid function Hyperprolactinemia (untreated) Abnormal, undiagnosed, gynecological bleeding Known current American Society Reproductive Medicine (ASRM) Stage 3 or 4 endometriosis A residual ovarian cyst with a mean diameter >25 mm or an estradiol (E2) >100 pg/mL at the baseline examination Three or more consecutive pregnancy losses, due to any cause Known current substance abuse (including smokers consuming more than 5 cigarettes/day) Previous participation (within 3 months prior to study entry) in another investigational drug or drug delivery system trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Follitropin alfa injected by Pen device

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of subjects who prefer Gonal-f® Pen device compared to previously used injection for gonadotropin treatment

    Secondary Outcome Measures

    Number of subjects with categorical score on subject satisfaction questionnaire
    Percentage of subjects with induced ovulation
    Number of follicles categorized by size on r-hCG administration day
    Duration of follitropin alfa treatment
    Cumulative dose of follitropin alfa administered
    Percentage of subjects with pregnancy

    Full Information

    First Posted
    September 29, 2005
    Last Updated
    November 27, 2013
    Sponsor
    EMD Serono
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00230815
    Brief Title
    A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction
    Official Title
    A Phase IIIb, Prospective, Multicenter Trial to Evaluate Subject Satisfaction With Follitropin Alfa Injection Applied by Pen Device Compared With Other Injectable Gonadotropins in Oligoanovulatory Infertile Women Undergoing Ovulation Induction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    November 2005 (Actual)
    Study Completion Date
    November 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMD Serono

    4. Oversight

    5. Study Description

    Brief Summary
    This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and efficacy with follitropin alfa injection applied by Pen device compared with the subject's previous experience with injectable gonadotropins in oligoanovulatory infertile women undergoing ovulation induction

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    Oligoanovulatory infertility, Follitropin alfa, Pen device, Gonal-f®, Recombinant Human Choriogonadotropin (r-hCG), Ovidrel®

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Follitropin alfa injected by Pen device
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Follitropin alfa injected by Pen device
    Other Intervention Name(s)
    Gonal-f®
    Intervention Description
    Follitropin alfa will be injected subcutaneously by Pen device at a dose of 75 International Unit (IU) and 150 IU in subjects aged 18-34 and 35-40 years, respectively, for 5 days. Dose will be adjusted on stimulation Day 6 until ovulation triggering criteria will met.
    Intervention Type
    Device
    Intervention Name(s)
    Recombinant Human Choriogonadotropin (r-hCG)
    Other Intervention Name(s)
    Ovidrel®, Choriogonadotropin alfa
    Intervention Description
    Recombinant Human Choriogonadotropin (r-hCG) injection will be administered as a single dose of 250 microgram subcutaneously when at least 1 follicle, but not more than 3 follicles, reached a mean diameter greater than or equal to (>=)17 mm and estradiol levels are approximately 150 picogram per milliliter (pg/mL) per mature follicle.
    Primary Outcome Measure Information:
    Title
    Percentage of subjects who prefer Gonal-f® Pen device compared to previously used injection for gonadotropin treatment
    Time Frame
    Stimulation Day 6
    Secondary Outcome Measure Information:
    Title
    Number of subjects with categorical score on subject satisfaction questionnaire
    Time Frame
    Stimulation Day 1 and Day 6
    Title
    Percentage of subjects with induced ovulation
    Time Frame
    Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})
    Title
    Number of follicles categorized by size on r-hCG administration day
    Time Frame
    r-hCG administration day (end of stimulation cycle {approximately 6 days})
    Title
    Duration of follitropin alfa treatment
    Time Frame
    Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})
    Title
    Cumulative dose of follitropin alfa administered
    Time Frame
    Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})
    Title
    Percentage of subjects with pregnancy
    Time Frame
    Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 6 days})

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infertile woman wishing to conceive who has had at least 1 previous cycle of treatment with injectable gonadotropins within the past 6 months, excluding treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device, whose physician has recommended that she undergo ovulation induction. This inclusion criterion is modified to include subjects who had previous treatment with any gonadotropin multi-dose formulation in vials, excluding those gonadotropins administered by a Pen device Premenopausal and aged 18-40 years, inclusive Ovulatory dysfunction as defined by any of the following (a) usual cycle length less than (<) 21 or greater than (>) 35 days with at least 6 menses per year (b) usual cycle length > 35 days with less than 6 menses per year. Subjects in this group must have a positive response to a progesterone challenge within the past 6 months or during the screening period Spontaneous menses or a positive response to progestin withdrawal within 6 months of the start of gonadotropin therapy or positive response to clomiphene citrate withdrawal at least 30 days prior to start of gonadotropin therapy is acceptable to demonstrate induced menses Normal Papanicolaou (PAP) smear within 6 months prior to initial visit Male partner with an acceptable semen analysis within 6 months prior to study entry, according to the standard practice at the clinic, for ovulation induction. Use of donor sperm is acceptable Body mass index (BMI) less than 35.0 kilogram per square meter (kg/m^2). BMI = Body Weight / Height x Height (BMI is equal to body weight [kilogram {kg}] divided by Height * Height [square meter {m^2}]) Patency and apparent normality of at least 1 fallopian tube with an ipsilateral functional ovary, as documented by an hysterosonogram or hysterosalpingography (HSG) within 3 years prior to study entry Local laboratory screening results demonstrating the following, within the past year: (a) prolactin within normal limits (b) Follicle stimulating hormone (FSH) within the normal limit for the early follicular phase at the local laboratory (c) thyroid stimulating hormone (TSH) within normal limits. Subjects with low TSH levels who were receiving replacement therapy could be enrolled at the discretion of the Investigator Been willing and able to comply with the protocol for the duration of the study Voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure not part of normal medical care, with the understanding that consent could be withdrawn by the subject at any time without prejudice to their future medical care. The male partner must also have provided a written subject authorization under HIPAA Exclusion Criteria: Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening Previous treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device in the past 6 months Any significant allergic disease, which in the opinion of the Investigator could interfere with study treatment Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus Prior severe Ovarian Hyperstimulation Syndrome (OHSS) Significant allergic response to gonadotropin preparations Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term Clinically significant abnormal findings evident on a transvaginal pelvic ultrasound performed within 2 cycles (maximum 90 days) of study entry Poor response in a prior gonadotropin stimulation cycle, defined as an estradiol level < 100 pg/mL per mature follicle (>=16 mm mean diameter) Prior excessive response to gonadotropin stimulation as defined by development of >3 mature follicles at a treatment dose of 75 IU FSH Treatment with gonadotropins, clomiphene citrate, insulin-sensitizing agents (e.g., metformin, Avandia®) or Gonadotropin Releasing Hormone (GnRH) analogs within 1 month prior to study entry Hypothyroidism (untreated). Subjects with low Thyroid Stimulating Hormone (TSH) levels who were receiving replacement therapy (e.g., Synthroid) could be enrolled at the discretion of the Investigator if local laboratory results demonstrated satisfactory thyroid function Hyperprolactinemia (untreated) Abnormal, undiagnosed, gynecological bleeding Known current American Society Reproductive Medicine (ASRM) Stage 3 or 4 endometriosis A residual ovarian cyst with a mean diameter >25 mm or an estradiol (E2) >100 pg/mL at the baseline examination Three or more consecutive pregnancy losses, due to any cause Known current substance abuse (including smokers consuming more than 5 cigarettes/day) Previous participation (within 3 months prior to study entry) in another investigational drug or drug delivery system trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eduardo Kelly, MD, MBA
    Organizational Affiliation
    Sponsor GmbH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17022858
    Citation
    Somkuti SG, Schertz JC, Moore M, Ferrande L, Kelly E; Gonal-F Prefilled Pen in OI Study 24785 Group. Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Curr Med Res Opin. 2006 Oct;22(10):1981-96. doi: 10.1185/030079906X132604.
    Results Reference
    result
    Links:
    URL
    http://www.fertilitylifelines.com
    Description
    Full FDA approved prescribing information can be found here

    Learn more about this trial

    A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

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