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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00796289

Enrollment

350

Registered

2008-11-24

Start date

2009-02-28

Completion date

2010-01-31

Last updated

2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

anovulatory/oligoovulatory infertility

Brief summary

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.

Interventions

DRUGGnRH 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

DRUGclomiphene citrate

Oral, 50 mg daily for 5 days

DRUGplacebo clomiphene citrate

oral, taken for 5 days

DRUGplacebo GnRH patch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ovulation rate	30 days

Secondary

Measure	Time frame
Pregnancy rate	30 days
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)	30 days
Incidence of skin irritation	30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026