MENOPUR® Versus FOLLISTIM®

NCT00802360 | Completed Phase 4 Results

• 1 other identifier: 2008-04
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 7

Brief Summary

To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles

Conditions

Infertility

Keywords

Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Ongoing Pregnancy at Week 8

  The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.

  Week 8 (Week 6 of gestation)

Secondary Outcomes (10)

• Number of Follicles Observed at Day 15

  Day 15

• Number of Oocytes Retrieved at Day 18

  Approximately Day 18

• Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved

  Approximately Day 19

• Number of Embryos Transferred at Three Stages of Development

  Approximately Day 24

• Number of Embryos Frozen at Day 24

  Approximately Day 24

Study Arms (4)

Menopur/Endometrin

EXPERIMENTAL

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Drug: Menotropin; Drug: Progestrone vaginal insert; Drug: Ganirelix

Menopur/Progesterone in Oil

EXPERIMENTAL

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Drug: Menotropin; Drug: Progesterone in oil; Drug: Ganirelix

Follistim/Endometrin

ACTIVE COMPARATOR

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Drug: Progestrone vaginal insert; Drug: follitropin beta; Drug: Ganirelix

Follistim/Progesterone in Oil

ACTIVE COMPARATOR

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Drug: follitropin beta; Drug: Progesterone in oil; Drug: Ganirelix

Interventions

Menotropin DRUG

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.

Also known as: highly purified menotropins, Menopur®, hMG

Menopur/Endometrin; Menopur/Progesterone in Oil

Progestrone vaginal insert DRUG

100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.

Also known as: progesterone, Endometrin®

Follistim/Endometrin; Menopur/Endometrin

follitropin beta DRUG

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.

Also known as: Follistim Pen®, Follistim®

Follistim/Endometrin; Follistim/Progesterone in Oil

Progesterone in oil DRUG

50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.

Follistim/Progesterone in Oil; Menopur/Progesterone in Oil

Ganirelix DRUG

Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.

Also known as: ganirelix acetate, GnRH antagonist

Follistim/Endometrin; Follistim/Progesterone in Oil; Menopur/Endometrin; Menopur/Progesterone in Oil

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal females between the ages of 18 and 42 years
• Body mass index (BMI) of 18-34
• Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) \<15 IU/L and Estradiol (E2) within normal limits
• Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women \>38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
• Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
• Signed informed consent

You may not qualify if:

• Gestational or surrogate carrier, donor oocyte
• Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
• Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
• Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of \>2 previous failed in vitro fertilization (IVF) cycles.
• History of recurrent pregnancy loss (\>2).
• Presence of abnormal uterine bleeding of undetermined origin
• Current or recent substance abuse, including alcohol or smoking \>10 cigarettes per day
• Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
• Participation in any experimental drug study within 30 days prior to Screening
• Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration \[MESA\], testicular sperm extraction \[TESE\])

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (7)

Huntington Reproductive Center

Pasadena, California, 91105, United States

Location

San Diego Fertility Center

San Diego, California, 92130, United States

Location

Conceptions Reproductive Associates of Colorado

Littleton, Colorado, 80129, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

The Advanced IVF Institute; Charles E. Miller, MD & Associates

Naperville, Illinois, 60540, United States

Location

A Woman's Center for Reproductive Medicine

Baton Rouge, Louisiana, 70815, United States

Location

Center for Assisted Reproduction

Bedford, Texas, 76022, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Menotropins; Progesterone; follitropin beta; Oils; ganirelix; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones; Lipids

Limitations and Caveats

This was an exploratory study that could be used as the basis for larger, adequately-powered studies. This limitation is the reason no statistical analyses are offered for study outcomes.

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 2, 2011
• Results First Posted: August 30, 2011

Record last verified: 2011-10

Locations

US (7)