A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH
NCT ID: NCT00296465
Last Updated: 2011-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
132 participants
INTERVENTIONAL
2005-02-28
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lutrepulse® 5mcg IV
5.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
Pulsatile gonadotropin-releasing hormone (GnRH)
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
Lutrepulse® 10 mcg IV
10.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
Pulsatile gonadotropin-releasing hormone (GnRH)
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
Lutrepulse® 20 mcg SC
20.0 mcg Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
Pulsatile gonadotropin-releasing hormone (GnRH)
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
Placebo IV
Placebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
Placebo SC
Placebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days
Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
Clomiphene Citrate/Placebo IV
Oral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Clomiphene Citrate
Oral clomiphene citrate (over encapsulated) for 5 days
Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Clomiphene Citrate / Placebo SC
Oral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Clomiphene Citrate
Oral clomiphene citrate (over encapsulated) for 5 days
Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Interventions
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Pulsatile gonadotropin-releasing hormone (GnRH)
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Clomiphene Citrate
Oral clomiphene citrate (over encapsulated) for 5 days
Placebo Pulsatile GnRH
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Placebo Clomiphene Citrate
oral placebo clomiphene citrate for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Ferring Pharmaceuticals
Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Southern Fertility Center and Clinical Research
Metairie, Louisiana, United States
Countries
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Other Identifiers
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2004-05
Identifier Type: -
Identifier Source: org_study_id
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