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

NCT00296465 | Completed Phase 2 DMC

• 1 other identifier: 2004-05
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility.

Conditions

InFertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Day 16

Secondary Outcomes (1)

• Adverse events, including ovarian hyperstimulation syndrome (OHSS)

  Day 1 to week 5

Study Arms (7)

Lutrepulse® 5mcg IV

EXPERIMENTAL

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

Drug: Pulsatile gonadotropin-releasing hormone (GnRH); Drug: Placebo Clomiphene Citrate

Lutrepulse® 10 mcg IV

EXPERIMENTAL

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

Drug: Pulsatile gonadotropin-releasing hormone (GnRH); Drug: Placebo Clomiphene Citrate

Lutrepulse® 20 mcg SC

EXPERIMENTAL

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

Drug: Pulsatile gonadotropin-releasing hormone (GnRH); Drug: Placebo Clomiphene Citrate

Placebo IV

PLACEBO COMPARATOR

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

Drug: Placebo Pulsatile GnRH; Drug: Placebo Clomiphene Citrate

Placebo SC

PLACEBO COMPARATOR

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

Drug: Placebo Pulsatile GnRH; Drug: Placebo Clomiphene Citrate

Clomiphene Citrate/Placebo IV

ACTIVE COMPARATOR

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

Drug: Clomiphene Citrate; Drug: Placebo Pulsatile GnRH

Clomiphene Citrate / Placebo SC

ACTIVE COMPARATOR

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

Drug: Clomiphene Citrate; Drug: Placebo Pulsatile GnRH

Interventions

Pulsatile gonadotropin-releasing hormone (GnRH) DRUG

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

Also known as: Lutrepulse®

Lutrepulse® 10 mcg IV; Lutrepulse® 20 mcg SC; Lutrepulse® 5mcg IV

Clomiphene Citrate DRUG

Oral clomiphene citrate (over encapsulated) for 5 days

Also known as: Clomid

Clomiphene Citrate / Placebo SC; Clomiphene Citrate/Placebo IV

Placebo Pulsatile GnRH DRUG

Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks

Clomiphene Citrate / Placebo SC; Clomiphene Citrate/Placebo IV; Placebo IV; Placebo SC

Placebo Clomiphene Citrate DRUG

oral placebo clomiphene citrate for 5 days

Lutrepulse® 10 mcg IV; Lutrepulse® 20 mcg SC; Lutrepulse® 5mcg IV; Placebo IV; Placebo SC

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females between the ages of 18 (or 19 in the State of Alabama) and 40 years.
• Infertile due to ovulatory dysfunction as described below:
• Positive progesterone withdrawal test following the screening visit.
• 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
• Normal insulin sensitivity assessed as ratio of fasting blood glucose to fasting insulin \> 4.5 at Screening
• 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.
• Presence of both ovaries, without evidence of clinically significant abnormality, as detected by transvaginal ultrasound
• Normal transvaginal ultrasound with respect to uterus and adnexa (eg, no hydrosalpinx)
• 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).
• Negative serum pregnancy test (qualitative) prior to the progesterone test
• Desire to become pregnant

You may not qualify if:

• Requires donor oocytes or sperm
• Previous and current use of infertility modifiers, including insulin-sensitizing drugs
• Primary amenorrhea/hypogonadotropic hypogonadism (eg, isolated gonadotropin deficiency or evidence of primary/premature ovarian failure)
• Presence of any clinically relevant systemic disease (eg, diabetes mellitus, pituitary tumor, anorexia nervosa).
• 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.
• Any pregnancy within last 3 months prior to Screening.
• Patients with a body mass index (BMI) \>30 at time of Screening
• Total testosterone and DHEA-S \>1.5 times the upper limits of normal laboratory range and prolactin \> 20 ng/mL
• Presence of abnormal uterine bleeding of undetermined origin.
• Active or prior history of substance abuse
• History of chemotherapy (except for gestational conditions) or radiotherapy
• Currently breast feeding, pregnant or contraindication to pregnancy
• Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests.
• Documented intolerance or allergy to any of the medications used including the study medication
• Participation in any experimental drug study within 60 days prior to Screening

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Southern Fertility Center and Clinical Research

Metairie, Louisiana, 70002, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone; Clomiphene

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: February 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: May 19, 2011

Record last verified: 2011-05

Locations

US (1)