LutrePulse Hypogonadotropic Hypogonadism



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 40
Updated:2/1/2019
Start Date:February 2014
End Date:February 23, 2018

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

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Three Doses of Subcutaneous Pulsatile GnRH Administered Via OmniPod Pump for Ovulation Induction in Female Subjects With Primary Amenorrhea With Hypogonadotropic Hypogonadism

To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic
hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the
OmniPod pump versus placebo


Inclusion Criteria:

- Women 18-40 years old

- Body mass index (BMI) between 18 and 38 kg/m2

- Clinical history or recently diagnosed with primary amenorrhea with hypogonadotropic
hypogonadism

- Hormonal values in a centrally analyzed fasting blood sample: FSH <5 IU/L and mean LH
<5 IU/L

- Desire to become pregnant

- Discontinued estrogen-progesterone replacement therapy at least 1 month before
screening

- Negative progestin challenge test performed during screening

- PAP smear within 24 months of the initial visit

- Normal or stable CT scan or MRI scan of the hypothalamic pituitary region

- Prolactin and thyroid-stimulating hormone (TSH) within normal clinical laboratory
limits

- Male partner with normal semen analysis, including volume, liquefaction time, sperm
count, and motility, according to the local laboratory normal criteria, within the
past year

- Normal transvaginal ultrasound at screening with respect to uterus and adnexa
(presence of both ovaries and tubes, without evidence of clinically significant
abnormality) and with normal uterine cavity and normal cervix

- Tube patency on saline tubal perfusion, hysterosalpingography or laparoscopy on file
within the past 2 years

Exclusion Criteria:

- Any medical condition that may interfere with the absorption, distribution,
metabolism, or excretion of the drug

- A history of, or currently diagnosed with clinically important cardiovascular,
pulmonary (e.g. serious corticosteroid-dependent asthma), gastrointestinal, hepatic,
metabolic, renal, endocrinological (e.g. insulin dependent diabetes mellitus), or
neurological (e.g. epilepsy, serious migraine, central nervous system (CNS) lesions
(in cases where hypogonadotropic hypogonadism is secondary to a CNS lesion or its
treatment) abnormality

- A history of adrenal or uncontrolled thyroid disorders, or hyperprolactinemia

- Prior treatment cycle with gonadotropins or GnRH within the last 2 months

- Known allergy to study drug or its components

- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C

- Ovarian enlargement or cyst of unknown etiology

- Abnormal gynecological bleeding of undetermined origin

- Previous or current hormone-dependent tumor

- Known active substance abuse

- Planning to undergo in vitro fertilization procedure in the course of a study
treatment cycle

- Currently undergoing treatment with gonadotropin hormones (FSH and LH), psychotropic
medication, sex hormones, or any other medication known to interfere with normal
reproductive function or that can affect GnRH secretion (e.g. neuroleptics, dopamine
antagonists, spironolactone, levodopa, phenothiazine, digoxin)

- Ongoing pregnancy or lactation
We found this trial at
34
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Abington, Pennsylvania
?
mi
from
Abington, PA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
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
Bryn Mawr, Pennsylvania 19010
?
mi
from
Bryn Mawr, PA
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60610
?
mi
from
Chicago, 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
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77063
?
mi
from
Houston, TX
Click here to add this to my saved trials
Louisville, Kentucky 40291
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Memphis, Tennessee 38120
?
mi
from
Memphis, TN
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newark, DE
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32804
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pleasant Grove, Utah 84062
?
mi
from
Pleasant Grove, UT
Click here to add this to my saved trials
Portland, Maine
?
mi
from
Portland, ME
Click here to add this to my saved trials
San Francisco, California
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Tempe, Arizona 85284
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Vancouver, British Columbia
?
mi
from
Vancouver,
Click here to add this to my saved trials
Washington, District of Columbia 20037
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Webster, TX
Click here to add this to my saved trials
Wichita, Kansas 67226
?
mi
from
Wichita, KS
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
?
mi
from
Winston-Salem, NC
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