Clinical Trial: LutrePulse Hypogonadotropic Hypogonadism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Pr

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

Detailed Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: Ovulation rate [ Time Frame: Treatment Days 19 - 25 ]

calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL


Original Primary Outcome: Ovulation rate [ Time Frame: Treatment Days 19 - 25 ]

calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 4 ng/mL


Current Secondary Outcome:

  • 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 ]
  • Proportion of subjects with a confirmed positive serum pregnancy test after luteinizing hormone (LH) surge [ Time Frame: Approximately 14 days after LH surge ]
  • 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 ]
  • 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 ]
  • Maximum progesterone levels [ Time Frame: Treatment Days 19, 21, 23, 25, and 27 ]
  • Mean progesterone levels [ Time Frame: Treatment Days 19, 21, 23, 25, and 27 ]
  • Change from baseline in follicle-stimulating hormone (FSH) and LH [ Time Frame: Treatment Days 1 and 10 ]
  • Mean serum FSH and LH levels [ Time Frame: Treatment Days 1 and 10 ]
  • Estradiol serum levels [ Time Frame: At treatment Day 1 and Day 10 ]
  • Proportion of subjects with at least 1 post-baseline progesterone level ≥ 10 ng/mL [ Time Frame: Treatment Days 19 - 25 ]


Original Secondary Outcome:

  • 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 ]
  • Proportion of subjects with a confirmed positive serum pregnancy test after luteinizing hormone (LH) surge [ Time Frame: Approximately 14 days after LH surge ]
  • 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 ]
  • 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 ]
  • Maximum progesterone levels [ Time Frame: Treatment Days 19, 22, 25, 28, and 31 ]
  • Mean progesterone levels [ Time Frame: Treatment Days 19, 22, 25, 28, and 31 ]
  • Change from baseline in follicle-stimulating hormone (FSH) and LH [ Time Frame: Treatment Days 1 and 10 ]
  • Mean serum FSH and LH levels [ Time Frame: Treatment Days 1 and 10 ]
  • Estradiol serum levels [ Time Frame: At treatment Day 1 and Day 10 ]


Information By: Ferring Pharmaceuticals

Dates:
Date Received: October 15, 2013
Date Started: February 2014
Date Completion: June 2019
Last Updated: May 1, 2017
Last Verified: May 2017