Trial · Interventional

CompletedPhase 3Results postedRegistry data

LutrePulse Hypogonadotropic Hypogonadism

NCTNCT01976728Other id000070

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 39 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Canada
Start: 1 Apr 2014
Primary completion: 23 Feb 2018
Completion: 23 Feb 2018
First posted: 6 Nov 2013 (estimated)
Last update posted: 3 Mar 2021
Conditions: Primary Amenorrhea With Hypogonadotropic Hypogonadism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420152016201720182019

Ph 3
LutrePulse Hypogonadotropic Hypogonadism
NCT01976728
1 Apr 2014 to 23 Feb 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pumpDrug
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pumpDrug
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pumpDrug
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)Drug

Arms4

Experimental
LutrePulse 10 µg/pulse
Gonadorelin acetate 10 µg/pulse
Experimental
LutrePulse 15 µg/pulse
Gonadorelin acetate 15 µg/pulse
Experimental
LutrePulse 20 µg/pulse
Gonadorelin acetate 20 µg/pulse
Placebo comparator
Placebo
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Ovulation Rate
Time frame · From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks
Registry description
Calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL or subjects with confirmed positive serum β-human chorionic gonadotropin (β-hCG) (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS).

Secondary outcomes(15)

Progesterone (P4) Levels
Time frame · Treatment Days 19, 21, 23, 25, and 27
Registry description
Proportion of participants with at least 1 post-baseline P4 level ≥ 10 ng/mL.
Clinical Pregnancy Rate
Time frame · 2 to 4 weeks after a second positive serum β-hCG test
Registry description
Proportion of subjects with presence of gestational sac and fetal heart movement on TVUS after a second positive serum β-hCG test.
Biochemical Pregnancy Rate
Time frame · Approximately 14 days after LH surge
Registry description
Proportion of subjects with a confirmed positive serum β-hCG test after luteinizing hormone (LH) surge.
LH Surge Detection
Time frame · Daily from Day 11 until first positive LH surge or until Day 39
Registry description
Proportion of subjects with a positive detection of LH surge, based on a Clearblue test which began when follicles with a mean diameter ≥14 mm were documented on TVUS.
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Time frame · From treatment Day 10 to treatment Day 21
Registry description
Number of follicles with a mean diameter ≥14 mm collected from Days 10 or 11, until LH surge or Day 21.
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Time frame · From treatment Day 10 to treatment Day 21
Registry description
Number of dominant follicles with a mean diameter ≥18 mm collected from Days 10 or 11, until LH surge or Day 21.
Luteal Phase Support: Maximum P4 Levels
Time frame · Treatment Days 19, 21, 23, 25, and 27
Registry description
Maximum of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Luteal Phase Support: Mean P4 Levels
Time frame · Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27
Registry description
Mean of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Change From Baseline in Follicle-stimulating Hormone (FSH)
Time frame · Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Registry description
FSH change from baseline in relation to the first dose (pulse) on Day 1 and Day 10
Change From Baseline in LH
Time frame · Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Registry description
LH change from baseline in relation to first dose (pulse) on Day 1 and Day 10
Mean Serum FSH and LH Levels
Time frame · Treatment Days 1 and Day 10
Registry description
Mean FSH and LH levels on Day 1 and Day 10.
Estradiol (E2) Serum Levels
Time frame · At treatment Day 1 and Day 10
Registry description
E2 serum levels on Day 1 and Day 10.
Type, Intensity, and Frequency of Adverse Events (AEs)
Time frame · From treatment Day 1 to end-of-trial, approximately 10 weeks
Registry description
An AE was defined as any untoward medical occurrence in a subject taking part in a clinical trial. Proportion of subjects with any AE (serious or non-serious) and intensity of AEs (classified as mild, moderate or severe) are presented.
Hematology, Clinical Chemistry, and Urinalysis
Time frame · From treatment Day 1 to end-of-trial, approximately 10 weeks
Registry description
Proportion of subjects with markedly abnormal changes in hematology, clinical chemistry, and urinalysis.
Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame · From treatment Day 1 to end-of-trial, approximately 10 weeks
Registry description
Proportion of subjects reporting OHSS classified as mild, moderate, or severe.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks

Ovulation Rate

Group	Value (Participants)
LutrePulse 10 µg/Pulse	1
LutrePulse 15 µg/Pulse	4
LutrePulse 20 µg/Pulse	5
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled	9
Placebo	0

Secondary and other outcome results(7)

Secondary outcomeCount of participants· Treatment Days 19, 21, 23, 25, and 27

Progesterone (P4) Levels

Group	Value (Participants)
LutrePulse 10 µg/Pulse	1
LutrePulse 15 µg/Pulse	4
LutrePulse 20 µg/Pulse	3
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled	7
Placebo	0

Secondary outcomeCount of participants· 2 to 4 weeks after a second positive serum β-hCG test

Clinical Pregnancy Rate

Group	Value (Participants)
LutrePulse 10 µg/Pulse	0
LutrePulse 15 µg/Pulse	2
LutrePulse 20 µg/Pulse	5
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled	7
Placebo	0

Secondary outcomeCount of participants· Approximately 14 days after LH surge

Biochemical Pregnancy Rate

Group	Value (Participants)
LutrePulse 10 µg/Pulse	0
LutrePulse 15 µg/Pulse	3
LutrePulse 20 µg/Pulse	5
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled	8
Placebo	0

Secondary outcomeCount of participants· Daily from Day 11 until first positive LH surge or until Day 39

LH Surge Detection

Group	Value (Participants)
LutrePulse 10 µg/Pulse	3
LutrePulse 15 µg/Pulse	7
LutrePulse 20 µg/Pulse	6
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled	13
Placebo	0

Secondary outcomeMedian· From treatment Day 10 to treatment Day 21

Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm

Group	Value (follicles)
LutrePulse 10 µg/Pulse	0.0
LutrePulse 15 µg/Pulse	0.0
LutrePulse 20 µg/Pulse	0.0
Placebo	0.0

Secondary outcomeMedian· From treatment Day 10 to treatment Day 21

Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm

Group	Value (follicles)
LutrePulse 10 µg/Pulse	0.0
LutrePulse 15 µg/Pulse	0.0
LutrePulse 20 µg/Pulse	0.0
Placebo	0.0

Secondary outcomeMedian· Treatment Days 19, 21, 23, 25, and 27

Luteal Phase Support: Maximum P4 Levels

Group	Value (ng/mL)
LutrePulse 10 µg/Pulse	0.40
LutrePulse 15 µg/Pulse	2.40
LutrePulse 20 µg/Pulse	8.00
Placebo	0.30

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LutrePulse 10 µg/PulseGonadorelin acetate SC 10 µg/pulse as a fixed dose, administered via. OmniPod pump	0 / 10	0 / 10	5 / 10
LutrePulse 15 µg/PulseGonadorelin acetate SC 15 µg/pulse as a fixed dose, administered via. OmniPod pump	0 / 8	0 / 8	3 / 8
LutrePulse 20 µg/PulseGonadorelin acetate SC 20 µg/pulse as a fixed dose, administered via. OmniPod pump	0 / 10	0 / 10	4 / 10
PlaceboPlacebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)	0 / 11	0 / 11	4 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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