Primary Amenorrhea With Hypogonadotropic HypogonadismPhase 3NCT01976728
LutrePulse Hypogonadotropic Hypogonadism
A Phase 3 study testing Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump and Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump in people with Primary Amenorrhea With Hypogonadotropic Hypogonadism, run by Ferring Pharmaceuticals at 35 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Primary Amenorrhea With Hypogonadotropic Hypogonadism
- What is being tested?
- Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump and Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 1 Apr 2014to 23 Feb 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States33 sites
Abington Reproductive Medicine, PC
Abington, Pennsylvania
Georgia Reproductive Specialists
Atlanta, Georgia
University of Colorado School of Medicine
Aurora, Colorado
Center for Assisted Reproduction
Bedford, Texas
Massachusetts General Hospital
Boston, Massachusetts
Main Line Fertility Center
Bryn Mawr, Pennsylvania
Carolinas HealthCare System
Charlotte, North Carolina
Fertility Centers of Illinois
Chicago, Illinois
Institute for Reproductive Health
Cincinnati, Ohio
University of Cincinnati Physicians
Cincinnati, Ohio
Women's Medical Research Group, LLC
Clearwater, Florida
UH Case Medical Center, MacDonald Clinical Trials
Cleveland, Ohio
Ohio Reproductive Medicine
Columbus, Ohio
Penn State MS Hershey Medical Center, Penn State College of Medicine
Hershey, Pennsylvania
Houston Fertility Institute
Houston, Texas
Bluegrass Clinical Research Inc.
Louisville, Kentucky
Fertility Associates of Memphis PLLC
Memphis, Tennessee
Weill Cornell Medical College
New York, New York
Reproductive Associates of Delaware
Newark, Delaware
Jones Institute for Reproductive Medicine
Norfolk, Virginia
University of Oklahoma Health Sciences Center, Abington IVF & Genetics, L.P.
Oklahoma City, Oklahoma
Center for Reproductive Medicine
Orlando, Florida
University of Pittsburgh, Magee-Womens Hospital
Pittsburgh, Pennsylvania
Utah Fertility Center
Pleasant Grove, Utah
Maine Medical Center-REI
Portland, Maine
Center for Reproductive Health UCSF
San Francisco, California
Wayne State University Physicians Group
Southfield, Michigan
Fertility Treatment Center
Tempe, Arizona
Columbia Fertility Associates
Washington D.C., District of Columbia
Center of Reproductive Medicine
Webster, Texas
Cypress Medical Research Center
Wichita, Kansas
Lyndhurst Clinical Research
Winston-Salem, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina
Canada2 sites
Ovo
Montreal, Quebec
Olive Fertility Centre
Vancouver, British Columbia
About this study
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
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
- Being tested
- Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump, Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pumpDrug
Also called LutrePulse
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pumpDrug
Also called LutrePulse
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pumpDrug
Also called LutrePulse
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)Drug
| Study group | Role | What they receive |
|---|---|---|
| LutrePulse 10 µg/pulse | Experimental | Gonadorelin acetate 10 µg/pulse Receives: Drug: Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump |
| LutrePulse 15 µg/pulse | Experimental | Gonadorelin acetate 15 µg/pulse Receives: Drug: Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump |
| LutrePulse 20 µg/pulse | Experimental | Gonadorelin acetate 20 µg/pulse Receives: Drug: Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Rate
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).
Measured: From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks
Secondary outcomes (15)
Progesterone (P4) Levels
Proportion of participants with at least 1 post-baseline P4 level ≥ 10 ng/mL.
Measured: Treatment Days 19, 21, 23, 25, and 27
Clinical Pregnancy Rate
Proportion of subjects with presence of gestational sac and fetal heart movement on TVUS after a second positive serum β-hCG test.
Measured: 2 to 4 weeks after a second positive serum β-hCG test
Biochemical Pregnancy Rate
Proportion of subjects with a confirmed positive serum β-hCG test after luteinizing hormone (LH) surge.
Measured: Approximately 14 days after LH surge
LH Surge Detection
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.
Measured: Daily from Day 11 until first positive LH surge or until Day 39
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Number of follicles with a mean diameter ≥14 mm collected from Days 10 or 11, until LH surge or Day 21.
Measured: From treatment Day 10 to treatment Day 21
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Number of dominant follicles with a mean diameter ≥18 mm collected from Days 10 or 11, until LH surge or Day 21.
Measured: From treatment Day 10 to treatment Day 21
Luteal Phase Support: Maximum P4 Levels
Maximum of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Measured: Treatment Days 19, 21, 23, 25, and 27
Luteal Phase Support: Mean P4 Levels
Mean of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Measured: Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27
Change From Baseline in Follicle-stimulating Hormone (FSH)
FSH change from baseline in relation to the first dose (pulse) on Day 1 and Day 10
Measured: Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Change From Baseline in LH
LH change from baseline in relation to first dose (pulse) on Day 1 and Day 10
Measured: Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Mean Serum FSH and LH Levels
Mean FSH and LH levels on Day 1 and Day 10.
Measured: Treatment Days 1 and Day 10
Estradiol (E2) Serum Levels
E2 serum levels on Day 1 and Day 10.
Measured: At treatment Day 1 and Day 10
Type, Intensity, and Frequency of Adverse Events (AEs)
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.
Measured: From treatment Day 1 to end-of-trial, approximately 10 weeks
Hematology, Clinical Chemistry, and Urinalysis
Proportion of subjects with markedly abnormal changes in hematology, clinical chemistry, and urinalysis.
Measured: From treatment Day 1 to end-of-trial, approximately 10 weeks
Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Proportion of subjects reporting OHSS classified as mild, moderate, or severe.
Measured: From treatment Day 1 to end-of-trial, approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study start1 Apr 2014
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Amenorrhea With Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976728
- Sponsor's protocol ID
- 000070
- Status last verified
- Jan 2021
- First submitted
- 15 Oct 2013
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01976728
- Acronym / sponsor ID
- 000070
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LutrePulse 10 µg/pulse | Experimental | Drug: Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pumpGonadorelin acetate 10 µg/pulse |
| LutrePulse 15 µg/pulse | Experimental | Drug: Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pumpGonadorelin acetate 15 µg/pulse |
| LutrePulse 20 µg/pulse | Experimental | Drug: Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pumpGonadorelin acetate 20 µg/pulse |
| Placebo | Placebo comparator | Drug: Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pumpAlso: LutrePulse | Drug | LutrePulse 10 µg/pulse |
| Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pumpAlso: LutrePulse | Drug | LutrePulse 15 µg/pulse |
| Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pumpAlso: LutrePulse | Drug | LutrePulse 20 µg/pulse |
| Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump) | Drug | Placebo |
Primary outcome
Ovulation Rate
Time frame: From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks
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).
15 secondary outcomes
Progesterone (P4) Levels
Time frame: Treatment Days 19, 21, 23, 25, and 27
Clinical Pregnancy Rate
Time frame: 2 to 4 weeks after a second positive serum β-hCG test
Biochemical Pregnancy Rate
Time frame: Approximately 14 days after LH surge
LH Surge Detection
Time frame: Daily from Day 11 until first positive LH surge or until Day 39
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
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Time frame: From treatment Day 10 to treatment Day 21
Luteal Phase Support: Maximum P4 Levels
Time frame: Treatment Days 19, 21, 23, 25, and 27
Luteal Phase Support: Mean P4 Levels
Time frame: Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27
Change From Baseline in Follicle-stimulating Hormone (FSH)
Time frame: Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Change From Baseline in LH
Time frame: Baseline (pre-dose), Treatment Day 1, Treatment Day 10
Mean Serum FSH and LH Levels
Time frame: Treatment Days 1 and Day 10
Estradiol (E2) Serum Levels
Time frame: At treatment 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
Hematology, Clinical Chemistry, and Urinalysis
Time frame: From treatment Day 1 to end-of-trial, approximately 10 weeks
Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: From treatment Day 1 to end-of-trial, approximately 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump and Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump in people with Primary Amenorrhea With Hypogonadotropic Hypogonadism, run by Ferring Pharmaceuticals at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation Rate (time frame: From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.