LutrePulse Hypogonadotropic Hypogonadism

This study is currently recruiting participants.
Verified February 2014 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01976728
First received: October 15, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Primary Amenorrhea With Hypogonadotropic Hypogonadism
Drug: Gonadorelin acetate 10µg/pulse
Drug: Gonadorelin acetate 20µg/pulse
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Two Doses of Subcutaneous Pulsatile GnRH Administered Via OmniPod Pump for Ovulation Induction in Female Subjects With Primary Amenorrhea With Hypogonadotropic Hypogonadism

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Ovulation rate [ Time Frame: Treatment Days 19 - 25 ] [ Designated as safety issue: No ]
    calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 4 ng/mL


Secondary Outcome Measures:
  • Proportion of subjects with presence of gestational sac and fetal heart movement on transvaginal ultrasound after a second positive serum pregnancy test [ Time Frame: 2 to 4 weeks after a second positive pregnancy test ] [ Designated as safety issue: No ]
  • Proportion of subjects with a confirmed positive serum pregnancy test after luteinizing hormone (LH) surge [ Time Frame: Approximately 14 days after LH surge ] [ Designated as safety issue: No ]
  • Number of follicles with a mean diameter ≥14 mm [ Time Frame: From Day 10 of the treatment period up to approximately 21 full treatment days ] [ Designated as safety issue: No ]
  • Number of dominant follicles with a mean diameter of ≥ 18mm [ Time Frame: From Day 10 of the treatment period up to approximately 21 full treatment days ] [ Designated as safety issue: No ]
  • Maximum progesterone levels [ Time Frame: Treatment Days 19, 22, 25, 28, and 31 ] [ Designated as safety issue: No ]
  • Mean progesterone levels [ Time Frame: Treatment Days 19, 22, 25, 28, and 31 ] [ Designated as safety issue: No ]
  • Change from baseline in follicle-stimulating hormone (FSH) and LH [ Time Frame: Treatment Days 1 and 10 ] [ Designated as safety issue: No ]
  • Mean serum FSH and LH levels [ Time Frame: Treatment Days 1 and 10 ] [ Designated as safety issue: No ]
  • Estradiol serum levels [ Time Frame: At treatment Day 1 and Day 10 ] [ Designated as safety issue: No ]
  • Proportion of subjects with at least 1 post-baseline progesterone level ≥ 10 ng/mL [ Time Frame: Treatment Days 19 - 25 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LutrePulse 10µg/pulse
Gonadorelin acetate 10µg/pulse
Drug: Gonadorelin acetate 10µg/pulse
Other Name: LutrePulse
Experimental: LutrePulse 20µg/pulse
Gonadorelin acetate 20µg/pulse
Drug: Gonadorelin acetate 20µg/pulse
Other Name: LutrePulse
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18-40 years old
  • Body mass index (BMI) between 18 and 32 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01976728

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

  Show 24 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01976728     History of Changes
Other Study ID Numbers: 000070
Study First Received: October 15, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amenorrhea
Hypogonadism
Menstruation Disturbances
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014