AmenorrheaPhase 1NCT07152730
A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump
A Phase 1 study testing Lutrepulse in people with Amenorrhea and Fertility, run by Ferring Pharmaceuticals at 1 site in United States.
Trial summary
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses. The results of this leads to anovulation and cessation of the menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea, Fertility, Infertility
- What is being tested?
- Lutrepulse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 29 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects 18 to 40 years old (both included).
- Body mass index (BMI) between 18 and 30 kg/m2 (both included).
- Regular menstrual cycles of 24 to 35 days (both included).
Who cannot join
- Any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, or excretion of gonadotropin-releasing hormone (GnRH).
- Use of any hormonal contraceptives, growth hormone, insulin or thyroid hormone replacement therapy 30 days prior to dosing in this trial.
- Previously known or suspected hypersensitivity to GnRH.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Trial Investigating the PK of Gonadotropin Releasing Hormone (GnRH) Administrated Subcutaneously Via the OmniPod Delivery System in Healthy Female Subjects
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses. The results of this leads to anovulation and cessation of the menstrual cycle. Pulsatile GnRH has been widely used in the United States (US), Canada, and Europe for almost 40 years in the treatment of primary hypothalamic amenorrhea. It has a favorable safety profile and a high degree of effectiveness in enabling ovulation and spontaneous pregnancy. At the moment there are no other GnRH products on the market, nor are there any other drugs marketed for induction of ovulation in women with primary hypothalamic amenorrhea in the US, creating a clear unmet medical need. The goal of this trial is to characterize the exposure variability of GnRH when administered via the OmniPod.
- Conditions
- Amenorrhea, Fertility, Infertility
- Being tested
- Lutrepulse
- Keywords
- Amenorrhea, Lutrepulse, Fertility, OmniPod
- Medical subject headings
- Amenorrhea, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LutrepulseDrug
Lutrepulse administered via the OmniPod delivery pump
| Study group | Role | What they receive |
|---|---|---|
| Group A (single dose) | Experimental | Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Receives: Drug: Lutrepulse |
| Group B (multiple doses) | Experimental | Part 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse Receives: Drug: Lutrepulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: maximum observed plasma concentration from Part 1- Pulse 1
Measured: Up to 5 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 1- Pulse 1
Measured: Up to 5 days
AUC0-infinity: area under the concentration-time curve to infinity from Part 1- Pulse 1
Measured: Up to 5 days
Secondary outcomes (9)
tmax: time to maximum plasma concentration from Part 1- Pulse 1
Measured: Up to 5 days
λz; terminal elimination rate constant from Part 1- Pulse 1
Measured: Up to 5 days
t½; terminal elimination half-life from Part 1- Pulse 1
Measured: Up to 5 days
Cmax: maximum observed plasma concentration from Part 2 - Pulse 6
Measured: Up to 4 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 2 - Pulse 6
Measured: Up to 4 days
AUCtau: area under the concentration-time profile at steady-state from Part 2 - Pulse 6
Measured: Up to 4 days
tmax: time to maximum plasma concentration from Part 2 - Pulse 6
Measured: Up to 4 days
λz; terminal elimination rate constant from Part 2 - Pulse 6
Measured: Up to 4 days
t½; terminal elimination half-life from Part 2 - Pulse 6
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start12 Sep 2025
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Why it stopped: The decision to terminate development activities was based on business needs and unrelated to any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT07152730
- Sponsor's protocol ID
- 000438
- Other IDs
- U1111-1313-1848
- Status last verified
- Nov 2025
- First submitted
- 26 Aug 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial Investigating the PK of Gonadotropin Releasing Hormone (GnRH) Administrated Subcutaneously Via the OmniPod Delivery System in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT07152730
- Acronym / sponsor ID
- 000438
- Conditions
- Amenorrhea, Fertility, Infertility
- Keywords
- Amenorrhea, Lutrepulse, Fertility, OmniPod
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The decision to terminate development activities was based on business needs and unrelated to any safety or efficacy concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses. The results of this leads to anovulation and cessation of the menstrual cycle. Pulsatile GnRH has been widely used in the United States (US), Canada, and Europe for almost 40 years in the treatment of primary hypothalamic amenorrhea. It has a favorable safety profile and a high degree of effectiveness in enabling ovulation and spontaneous pregnancy. At the moment there are no other GnRH products on the market, nor are there any other drugs marketed for induction of ovulation in women with primary hypothalamic amenorrhea in the US, creating a clear unmet medical need. The goal of this trial is to characterize the exposure variability of GnRH when administered via the OmniPod.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (single dose) | Experimental | Drug: LutrepulseSingle-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse |
| Group B (multiple doses) | Experimental | Drug: LutrepulsePart 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy female subjects 18 to 40 years old (both included).
- Body mass index (BMI) between 18 and 30 kg/m2 (both included).
- Regular menstrual cycles of 24 to 35 days (both included).
Key exclusion criteria (3 listed)
- Any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, or excretion of gonadotropin-releasing hormone (GnRH).
- Use of any hormonal contraceptives, growth hormone, insulin or thyroid hormone replacement therapy 30 days prior to dosing in this trial.
- Previously known or suspected hypersensitivity to GnRH.
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 |
|---|---|---|
| LutrepulseLutrepulse administered via the OmniPod delivery pump | Drug | Group A (single dose), Group B (multiple doses) |
Primary outcome
Cmax: maximum observed plasma concentration from Part 1- Pulse 1
Time frame: Up to 5 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 1- Pulse 1
Time frame: Up to 5 days
AUC0-infinity: area under the concentration-time curve to infinity from Part 1- Pulse 1
Time frame: Up to 5 days
9 secondary outcomes
tmax: time to maximum plasma concentration from Part 1- Pulse 1
Time frame: Up to 5 days
λz; terminal elimination rate constant from Part 1- Pulse 1
Time frame: Up to 5 days
t½; terminal elimination half-life from Part 1- Pulse 1
Time frame: Up to 5 days
Cmax: maximum observed plasma concentration from Part 2 - Pulse 6
Time frame: Up to 4 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 2 - Pulse 6
Time frame: Up to 4 days
AUCtau: area under the concentration-time profile at steady-state from Part 2 - Pulse 6
Time frame: Up to 4 days
tmax: time to maximum plasma concentration from Part 2 - Pulse 6
Time frame: Up to 4 days
λz; terminal elimination rate constant from Part 2 - Pulse 6
Time frame: Up to 4 days
t½; terminal elimination half-life from Part 2 - Pulse 6
Time frame: Up to 4 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lutrepulse in people with Amenorrhea and Fertility, run by Ferring Pharmaceuticals at 1 site in United States.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cmax: maximum observed plasma concentration from Part 1- Pulse 1 (time frame: Up to 5 days). The study lists 3 primary outcomes in all. 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 14 Nov 2025.