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Completed

NCT Number: NCT00796289

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

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.

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Key information

Conditions

Infertility Adnexal Diseases Anovulation Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Watching Over Mothers and Babies Foundation, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRH iontophoretic transdermal Lutrepatch

Drug

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)

Clomiphene Citrate

Drug

Oral, 50 mg daily for 5 days

Other names: various tradenames

Placebo Clomiphene Citrate

Drug

oral, taken for 5 days

placebo GnRH patch

Drug

Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.

Primary outcomes

  1. Ovulation rate

    Time frame: 30 days

Secondary outcomes

  1. Pregnancy rate

    Time frame: 30 days

  2. Incidence of Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame: 30 days

  3. Incidence of skin irritation

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Nov 24, 2008
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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