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



Status:Completed
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 38
Updated:10/14/2017
Start Date:February 2009
End Date:January 2010

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
35
sites
Baton Rouge, Louisiana 70815
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
?
mi
from
New York, NY
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
?
mi
from
Portland, ME
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Champaign, Illinois 61820
?
mi
from
Champaign, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45209
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33759
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Eugene, Oregon 97401
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hamtramck, MI
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Las Vegas, Nevada 89117
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lawrenceville, New Jersey 08648
?
mi
from
Lawrenceville, NJ
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Lincoln, Nebraska 68510
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Portland, Oregon 97239
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Reno, NV
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
San Diego, California 92130
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Ramon, California 94583
?
mi
from
San Ramon, CA
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Vista, CA
Click here to add this to my saved trials
?
mi
from
Webster, TX
Click here to add this to my saved trials
Westlake Village, California 91361
?
mi
from
Westlake Village, CA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials