Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00805935
• Date of registration: 09/12/2008
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
• Scientific title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients
• Date of first enrolment: January 2009
• Target sample size: 110
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00805935
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion criteria

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
day

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



Age minimum: 18 Years
Age maximum: 42 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Polycystic Ovarian Syndrome

Infertility

Intervention(s)

Drug: Follitropin beta

Drug: Progesterone in oil

Drug: Progesterone vaginal insert

Drug: Menotropin

Drug: leuprolide acetate

Primary Outcome(s)

Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 [Time Frame: weeks 1-3]

Secondary Outcome(s)

Estradiol Levels at Day 6 [Time Frame: Day 6]

Number of Embryos Transferred at Three Stages of Development Before Implantation [Time Frame: approximately day 24]

Number of Follicles Observed at Day 15 [Time Frame: approximately day 15]

Number of Oocytes Retrieved at Day 18 [Time Frame: approximately day 18]

Participants With Treatment Emergent Adverse Events [Time Frame: Week 1 to week12]

Percentage of Participants With Biochemical Pregnancy at Approximately Day 38 [Time Frame: approximately day 38 (Day 14 post embryo transfer)]

Percentage of Participants With Clinical Pregnancy at Week 7 [Time Frame: approximately Day 52]

Percentage of Participants With Ongoing Pregnancy at Week 9 [Time Frame: approximately Day 65]

Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration [Time Frame: approximately day 16]

Human Chorionic Gonadotropin (hCG) Levels at Day 6 [Time Frame: Day 6]

Number of Embryos Frozen [Time Frame: approximately day 24]

Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved [Time Frame: approximately day 19]

Number of Live Births Resulting From the In Vitro Fertilization Process [Time Frame: Approximately 10 months]

Secondary ID(s)

2008-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/01/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00805935