Clinical trial NCT00230815: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Oligoanovulatory infertility
Follitropin alfa
Pen device
Gonal-f®
Recombinant Human Choriogonadotropin (r-hCG)
Ovidrel®
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of subjects who prefer Gonal-f® Pen device compared to previously used injection for gonadotropin treatment
timeFrame: Stimulation Day 6
Secondary outcomes:
measure: Number of subjects with categorical score on subject satisfaction questionnaire
timeFrame: Stimulation Day 1 and Day 6
measure: Percentage of subjects with induced ovulation
timeFrame: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})
measure: Number of follicles categorized by size on r-hCG administration day
timeFrame: r-hCG administration day (end of stimulation cycle {approximately 6 days})
measure: Duration of follitropin alfa treatment
timeFrame: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})
measure: Cumulative dose of follitropin alfa administered
timeFrame: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})
measure: Percentage of subjects with pregnancy
timeFrame: Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 6 days})
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Eduardo Kelly, MD, MBA
role: STUDY_DIRECTOR
References:
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.