Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00796289
First received: November 20, 2008
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.


Condition Intervention Phase
Infertility
Drug: GnRH iontophoretic transdermal Lutrepatch
Drug: clomiphene citrate
Drug: placebo clomiphene citrate
Drug: placebo GnRH patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch (Lutrepatch) Compared to Oral Treatment With Clomiphene Citrate or Placebo in Anovulatory or Oligoovulatory Infertile Females

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Ovulation rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of skin irritation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 350
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GnRH High Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
Drug: GnRH iontophoretic transdermal Lutrepatch
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'high target' study dose, which is estimated to be 800 picograms/ml
Other Names:
  • Lutrepatch
  • Gonadotropin-releasing hormone (GnRH)
Drug: placebo clomiphene citrate
oral, taken for 5 days
Experimental: GnRH Medium Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a medium target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
Drug: GnRH iontophoretic transdermal Lutrepatch
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day(every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'medium target' study dose, which is estimated to be 400-600 picograms/ml
Other Names:
  • Gonadotropin-releasing hormone (GnRH)
  • Lutrepatch
Drug: placebo clomiphene citrate
oral, taken for 5 days
Experimental: GnRH Low Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a low target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
Drug: GnRH iontophoretic transdermal Lutrepatch
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'low target' study dose, which is estimated to be 200 picograms/ml
Other Names:
  • Gonadotropin-releasing hormone (GnRH)
  • Lutrepatch
Drug: placebo clomiphene citrate
oral, taken for 5 days
Active Comparator: Clomiphene Citrate
Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral 50 mg clomiphene citrate for 5 days
Drug: clomiphene citrate
Oral, 50 mg daily for 5 days
Other Name: various tradenames
Drug: placebo GnRH patch
Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.
Placebo Comparator: Placebo
Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
Drug: placebo clomiphene citrate
oral, taken for 5 days
Drug: placebo GnRH patch
Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females between the ages of 18 and 38 years
  2. Desire to become pregnant
  3. Infertile due to ovulatory dysfunction as described below:

    • Unable to conceive for at least 1 year and
    • Anovulatory (defined as 4 or fewer menstrual cycles per year) or Oligo-ovulatory (defined as menstrual cycle frequency > 45 days)

Exclusion Criteria:

  1. Requires donor oocytes or sperm
  2. Two or more failed (defined as no biochemical pregnancy achieved) gonadotropin fertility treatment cycles - if previous gonadotropin success, no more than two failed subsequent cycles
  3. Use of insulin-sensitizing drugs (e.g., Metformin) within 1 month prior to progesterone challenge
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796289

  Show 35 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00796289     History of Changes
Other Study ID Numbers: 2008-03
Study First Received: November 20, 2008
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
anovulatory/oligoovulatory infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Clomiphene
Enclomiphene
Zuclomiphene
Citric Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Anticoagulants
Hematologic Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014