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 - Full Text View

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00796289

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Infertility

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Gonadorelin Gonadorelin hydrochloride Citric acid Clomiphene Sodium Citrate trans-Clomifene citrate LH-RH

U.S. FDA Resources

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 ]

Estimated Enrollment:	500
Study Start Date:	February 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GnRH High Target Delivery: Experimental 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 Drug: placebo clomiphene citrate oral, taken for 5 days
GnRH Medium Target Delivery: Experimental 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 Drug: placebo clomiphene citrate oral, taken for 5 days
GnRH Low Target Delivery: Experimental 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 Drug: placebo clomiphene citrate oral, taken for 5 days
Clomiphene Citrate: Active Comparator 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 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: Placebo Comparator 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:

Females between the ages of 18 and 38 years
Desire to become pregnant
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:

Requires donor oocytes or sperm
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
Use of insulin-sensitizing drugs (e.g., Metformin) within 1 month prior to progesterone challenge

Contacts and Locations

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

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

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 ( Clinical Development Support )
Study ID Numbers:	2008-03
Study First Received:	November 20, 2008
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00796289 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:

anovulatory/oligoovulatory infertility

Additional relevant MeSH terms:

Infertility
Estrogen Antagonists
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Citric Acid
Hematologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Reproductive Control Agents

Selective Estrogen Receptor Modulators
Genital Diseases, Male
Hormones
Pharmacologic Actions
Genital Diseases, Female
Estrogen Receptor Modulators
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Chelating Agents

ClinicalTrials.gov processed this record on February 08, 2010