Gonadotropin-Releasing Hormone for Infertility

Overseen By Global Clinical Compliance

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Ferring Pharmaceuticals

Must not be taking: Hormonal contraceptives

Disqualifiers: Hypersensitivity to GnRH, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for women who have stopped ovulating due to hypothalamic amenorrhea, a condition where the brain fails to send the right signals to trigger ovulation. The treatment, Lutrepulse (a gonadotropin-releasing hormone therapy), aims to kickstart ovulation and help women potentially become pregnant. The trial seeks to understand how this treatment works when delivered through a special device called the OmniPod. Women with regular menstrual cycles who are otherwise healthy may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

If you are using hormonal contraceptives, growth hormone, insulin, or thyroid hormone replacement therapy, you will need to stop taking them at least 30 days before starting the trial.

What prior data suggests that this method is safe for treating hypothalamic amenorrhea?

Research has shown that pulsatile GnRH, a type of hormone therapy, effectively and safely helps women ovulate. This treatment has been used in the U.S., Canada, and Europe for nearly 40 years, primarily for women who have stopped having periods due to hormonal issues. It helps prevent ovarian hyperstimulation syndrome, a serious condition where the ovaries become too swollen.

Previous studies found the treatment well-tolerated, with only a few cases of multiple pregnancies and one instance of ovarian hyperstimulation, both linked to other medications. Overall, pulsatile GnRH is considered safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lutrepulse is unique because it uses a precise pulsatile delivery of gonadotropin-releasing hormone (GnRH), which is different from the continuous hormone treatments typically used for infertility. Traditional options often involve hormone injections or pills that can lead to side effects due to non-physiological hormone levels. Lutrepulse offers a more natural hormone rhythm by delivering small, controlled doses, potentially reducing side effects and improving effectiveness. Researchers are excited about its potential to mimic the body's natural hormone cycles more closely, promising a more effective and patient-friendly approach to treating infertility.

What is the effectiveness track record for Lutrepulse in treating hypothalamic amenorrhea?

This trial will compare different dosing regimens of Lutrepulse, a pulsatile GnRH therapy, for treating hypothalamic amenorrhea, a condition where menstrual periods stop. Research has shown that pulsatile GnRH therapy effectively helps women ovulate with fewer side effects than other hormone treatments. For nearly 40 years, this therapy has been used successfully in the U.S., Canada, and Europe, enabling many women to ovulate and become pregnant naturally. It is considered safe and reliable for those with this specific type of infertility. ^{2 6 7 8 9}

Who Is on the Research Team?

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for individuals with amenorrhea, a condition where menstrual periods are absent due to low GnRH pulses leading to anovulation. It's specifically aimed at those with primary hypothalamic amenorrhea who have not found other effective treatments for inducing ovulation and achieving pregnancy.

Inclusion Criteria

I am a healthy woman aged 18-40, with a BMI of 18-30 and regular menstrual cycles.

Exclusion Criteria

Previously known or suspected hypersensitivity to GnRH

I have a condition that could affect how my body handles certain hormone treatments.

I have not used hormonal contraceptives, growth hormone, insulin, or thyroid hormone replacement in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple doses of GnRH via the OmniPod system

1-2 weeks

1 visit (in-person) for single dose, multiple visits for multiple doses

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lutrepulse

Trial Overview The study is testing the delivery of Gonadotropin-Releasing Hormone (GnRH) using the OmniPod pump. The aim is to understand how consistently this method delivers GnRH into the body, which could help treat hypothalamic amenorrhea and improve fertility.

How Is the Trial Designed?

Group I: Group B (multiple doses) Experimental Treatment 1 Intervention

Part 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse

Group II: Group A (single dose) Experimental Treatment 1 Intervention

Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11927256/

Comparison of outcomes between pulsatile gonadotropin ... There was no difference in the efficiency of successfully inducing spermatogenesis between pulsatile GnRH therapy and hCG/HMG therapy (82.1% vs.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0015028217321751

Efficacy and safety of pulsatile gonadotropin-releasing ... Previous published data suggest that pGnRH is superior to conventional exogenous gonadotropin in achieving ovulation with a lower risk of adverse outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12068405/

Effects of Different Gonadotropin-Releasing Hormone ... Goserelin acetate was found to have good pregnancy outcomes in IVF/ICSI-ET with small amount and shout using days of gonadotropin.

4. cureus.com cureus.com/articles/255926-gonadotropin-releasing-hormone-gnrh-agonist-protocol-improves-pregnancy-outcomes-during-in-vitro-fertilization-ivf-and-intracytoplasmic-sperm-injection-icsi-treatment-in-young-infertile-women-a-retrospective-study

Gonadotropin-Releasing Hormone (GnRH) Agonist ... Comparison of pregnancy outcomes between two groups ; Clinical pregnancy rate (%), 61.54 (216/351), 47.30 (70/148), 0.037, 4.327 ; Live birth rate ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/000293789091441E

Efficacy and safety of intravenous pulsatile gonadotropin- ... A 12% incidence of multiple pregnancy was noted, and a single case of ovarian hyperstimulation was reported in a woman who also received clomiphene citrate.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10201297/

Pulsatile GnRH: Clinical Applications of Physiologic Paradigm Pulsatile GnRH ovulation induction is effective and safe because it allows to avoid ovarian hyperstimulation syndrome and reduce the occurrence of multiple ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00383656?term=nichd%20Amenorrhea&viewType=Table&rank=6

NCT00383656 | Pulsatile GnRH in Anovulatory Infertility The purpose of this study is to explore the effects of synthetic gonadotropin-releasing hormone (GnRH) upon the pituitary and ovaries of women with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9790838/

Use of pulsatile gonadotropin-releasing hormone (GnRH) in ... The pulsatile GnRH pump represents a safer and more physiologic alternative to ovulation induction with injectable gonadotropins.

9. link.springer.com link.springer.com/article/10.1007/s00404-024-07914-3

GnRH Agonist in Early Pregnancy: Adverse Outcomes Exposure to GnRH-a during the luteal phase of down-regulation can adversely affect pregnancy outcomes. Therefore, we recommend contraception ...