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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00230815
First received: September 29, 2005
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Infertility
Device: Follitropin alfa injected by Pen device
Device: Recombinant Human Choriogonadotropin (r-hCG)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Percentage of subjects who prefer Gonal-f® Pen device compared to previously used injection for gonadotropin treatment [ Time Frame: Stimulation Day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with categorical score on subject satisfaction questionnaire [ Time Frame: Stimulation Day 1 and Day 6 ] [ Designated as safety issue: No ]
  • Percentage of subjects with induced ovulation [ Time Frame: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days}) ] [ Designated as safety issue: No ]
  • Number of follicles categorized by size on r-hCG administration day [ Time Frame: r-hCG administration day (end of stimulation cycle {approximately 6 days}) ] [ Designated as safety issue: No ]
  • Duration of follitropin alfa treatment [ Time Frame: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days}) ] [ Designated as safety issue: No ]
  • Cumulative dose of follitropin alfa administered [ Time Frame: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days}) ] [ Designated as safety issue: No ]
  • Percentage of subjects with pregnancy [ Time Frame: Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 6 days}) ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: July 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Follitropin alfa injected by Pen device Device: Follitropin alfa injected by Pen device
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.
Other Name: Gonal-f®
Device: Recombinant Human Choriogonadotropin (r-hCG)
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.
Other Names:
  • Ovidrel®
  • Choriogonadotropin alfa

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230815

Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Eduardo Kelly, MD, MBA Sponsor GmbH
  More Information

Additional Information:
Publications:
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00230815     History of Changes
Other Study ID Numbers: 24785
Study First Received: September 29, 2005
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by EMD Serono:
Oligoanovulatory infertility
Follitropin alfa
Pen device
Gonal-f®
Recombinant Human Choriogonadotropin (r-hCG)
Ovidrel®

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Chorionic Gonadotropin
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014