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A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients

Phase 4
18 Years
42 Years
Not Enrolling
Polycystic Ovarian Syndrome, Infertility

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Trial Information

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients

Inclusion Criteria:

1. Pre-menopausal females between the ages of 18 and 42 years

2. Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003
Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies [congenital adrenal
hyperplasia, androgen-secreting tumors, Cushing's syndrome])

- Oligo- or anovulation

- Clinical and/or biochemical signs of hyperandrogenism

- Polycystic ovaries

3. Body mass index (BMI) of 18-39

4. Early follicular phase (Day 3) follicle stimulating hormone (FSH) < 15 IU/L and
estradiol (E2) within normal limits

5. 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.)

6. Transvaginal ultrasound at screening consistent with findings adequate for assisted
reproductive technology (ART) with respect to uterus and adnexa

7. Signed informed consent

Exclusion Criteria:

1. Gestational or surrogate carrier, donor oocyte

2. Presence of any clinically relevant systemic disease (e.g., uncontrolled thyroid or
adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor,
insulin-dependent diabetes mellitus, uterine cancer)

3. 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

4. Two or more previous failed in vitro fertilization (IVF) cycles or in vitro
fertilization (IVF)/assisted reproductive technology (ART) failure due to a poor
response to gonadotropins, defined as development of 2 mature follicles

5. History of recurrent pregnancy loss, defined as more than two clinical losses

6. Presence of abnormal uterine bleeding of undetermined origin

7. Current or recent substance abuse, including alcohol or smoking > 10 cigarettes per

8. Refusal or inability to comply with the requirements of the Protocol for any reason,
including scheduled clinic visits and laboratory tests

9. Participation in any experimental drug study within 30 days prior to Screening

10. Severe male factor requiring invasive or surgical sperm retrieval (e.g.,
microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])

11. Prior hypersensitivity to any of the protocol drugs

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3

Outcome Description:

A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).

Outcome Time Frame:

weeks 1-3

Safety Issue:


Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

September 2010

Related Keywords:

  • Polycystic Ovarian Syndrome
  • Infertility
  • pre-menopausal women
  • PCOS
  • polycystic ovarian syndrome
  • infertility
  • IVF
  • in vitro fertilization
  • Infertility
  • Polycystic Ovary Syndrome



Weill Cornell Medical CollegeNew York, New York  10021
Conceptions Reproductive Associates of ColoradoLittleton, Colorado  80129
Women's Medical Research Group LLC, FloridaClearwater, Florida  33759
Fertility Center of IllinoisChicago, Illinois  60610
Women & Infants' Hospital of RIProvidence, Rhode Island  02905
Center for Assisted ReproductionBedford, Texas  76022