A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00296465
• Date of registration: 23/02/2006
• Primary sponsor: Ferring Pharmaceuticals
• Public title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Administered Intravenously or Subcutaneously (Via Portable Infusion Pump) Compared to Oral Treatment With Clomiphene Citrate in Anovulatory or Oligoovulatory Infertile Females
• Date of first enrolment: February 2005
• Target sample size: 132
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00296465
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria

1. Females between the ages of 18 (or 19 in the State of Alabama) and 40 years.

2. Infertile due to ovulatory dysfunction as described below:

3. Positive progesterone withdrawal test following the screening visit.

4. TSH (thyroid-stimulating hormone) levels within normal limits for the clinical
laboratory or considered not clinically significant (eg, secondary to exogenous
thyroid medication) by the investigator

5. Normal insulin sensitivity assessed as ratio of fasting blood glucose to fasting
insulin > 4.5 at Screening

6. Male partner with recent (within 6 months prior to screening) semen analysis showing
normalcy according to the local laboratory normal criteria. If screening semen
analysis is borderline, the couple will be accepted into the study only if a second
sample obtained prior to screening is adequate.

7. Presence of both ovaries, without evidence of clinically significant abnormality, as
detected by transvaginal ultrasound

8. Normal transvaginal ultrasound with respect to uterus and adnexa (eg, no
hydrosalpinx)

9. Hysterosalpingography or hysteroscopy or sonohysterogram documenting a uterine cavity
consistent with expected normal function and patency of the fallopian tubes within
the previous 3 years prior to screening (within 1 year prior to screening there
should be no pelvic infection, endometriosis or pelvic surgery).

10. Negative serum pregnancy test (qualitative) prior to the progesterone test

11. Desire to become pregnant

Exclusion Criteria

1. Requires donor oocytes or sperm

2. Previous and current use of infertility modifiers, including insulin-sensitizing
drugs

3. Primary amenorrhea/hypogonadotropic hypogonadism (eg, isolated gonadotropin
deficiency or evidence of primary/premature ovarian failure)

4. Presence of any clinically relevant systemic disease (eg, diabetes mellitus,
pituitary tumor, anorexia nervosa).

5. 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.

6. Any pregnancy within last 3 months prior to Screening.

7. Patients with a body mass index (BMI) >30 at time of Screening

8. Total testosterone and DHEA-S >1.5 times the upper limits of normal laboratory range
and prolactin > 20 ng/mL

9. Presence of abnormal uterine bleeding of undetermined origin.

10. Active or prior history of substance abuse

11. History of chemotherapy (except for gestational conditions) or radiotherapy

12. Currently breast feeding, pregnant or contraindication to pregnancy

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

14. Documented intolerance or allergy to any of the medications used including the study
medication

15. Participation in any experimental drug study within 60 days prior to Screening



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

InFertility

Intervention(s)

Drug: Clomiphene Citrate

Drug: Placebo Clomiphene Citrate

Drug: Placebo Pulsatile GnRH

Drug: Pulsatile gonadotropin-releasing hormone (GnRH)

Primary Outcome(s)

Pregnancy rate [Time Frame: Day 16]

Secondary Outcome(s)

Adverse events, including ovarian hyperstimulation syndrome (OHSS) [Time Frame: Day 1 to week 5]

Secondary ID(s)

2004-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors