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LutrePulse Hypogonadotropic Hypogonadism

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ClinicalTrials.gov Identifier: NCT01976728
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Amenorrhea With Hypogonadotropic Hypogonadism Drug: Gonadorelin acetate 10µg/pulse Drug: Gonadorelin acetate 15µg/pulse Drug: Gonadorelin acetate 20µg/pulse Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 2014
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LutrePulse 10µg/pulse
Gonadorelin acetate 10µg/pulse
Drug: Gonadorelin acetate 10µg/pulse
Other Name: LutrePulse

Experimental: LutrePulse 15µg/pulse
Gonadorelin acetate 15µg/pulse
Drug: Gonadorelin acetate 15µg/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



Primary Outcome Measures :
  1. Ovulation rate [ Time Frame: To end of study, approximately 10 weeks ]
    Calculated as subjects with at least 1 post-baseline progesterone (P4) level ≥ 6 ng/mL or subjects with confirmed positive serum β-hCG (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS)


Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of subjects with a confirmed positive serum pregnancy test after luteinizing hormone (LH) surge [ Time Frame: Approximately 14 days after LH surge ]
  3. 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 ]
  4. 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 ]
  5. Maximum progesterone levels [ Time Frame: Treatment Days 19, 21, 23, 25, and 27 ]
  6. Mean progesterone levels [ Time Frame: Treatment Days 19, 21, 23, 25, and 27 ]
  7. Change from baseline in follicle-stimulating hormone (FSH) and LH [ Time Frame: Treatment Days 1 and 10 ]
  8. Mean serum FSH and LH levels [ Time Frame: Treatment Days 1 and 10 ]
  9. Estradiol serum levels [ Time Frame: At treatment Day 1 and Day 10 ]
  10. Proportion of subjects with at least 1 post-baseline progesterone level ≥ 10 ng/mL [ Time Frame: Treatment Days 19 - 25 ]
  11. Proportion of subjects with a positive detection of LH surge [ Time Frame: Daily from day 11 until first positive LH surge or until day 39 ]
    Based on a Clearblue test



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976728


  Show 35 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01976728     History of Changes
Other Study ID Numbers: 000070
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Hypogonadism
Amenorrhea
Gonadal Disorders
Endocrine System Diseases
Menstruation Disturbances
Pathologic Processes
Prolactin Release-Inhibiting Factors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs