4 Participants Needed

Kisspeptin for Polycystic Ovary Syndrome

SC
Overseen ByStudy Coordinator
Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: Stephanie B. Seminara, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

If you are using hormonal medications or any drugs that might affect the reproductive system, you may need to stop taking them and go through a washout period (time without taking certain medications) before joining the trial.

What evidence supports the effectiveness of the drug Kisspeptin for treating Polycystic Ovary Syndrome?

Research shows that a kisspeptin receptor agonist, MVT-602, can increase luteinizing hormone (LH) levels in women with PCOS, similar to its effects in healthy women, suggesting it may help regulate reproductive hormones. Additionally, kisspeptin levels are higher in women with PCOS, indicating its role in the condition and potential as a treatment target.12345

Is Kisspeptin safe for use in humans?

Kisspeptin has been studied for its role in reproductive health and has shown promise in treatments like in vitro fertilization (IVF) with reduced risk of complications. It has been used to stimulate hormone secretion in both healthy individuals and those with reproductive disorders, suggesting it is generally safe for human use.46789

How is the drug Kisspeptin different from other treatments for PCOS?

Kisspeptin is unique because it directly influences the release of gonadotropin-releasing hormone (GnRH), which is crucial for regulating hormones involved in ovulation. This makes it different from other treatments that may not target the hormonal imbalance at this specific level, potentially offering a novel approach for managing PCOS symptoms.310111213

What is the purpose of this trial?

This trial involves giving kisspeptin and another hormone to people with PCOS to see how it affects their hormone levels. The goal is to understand if kisspeptin can help regulate their reproductive hormones. Kisspeptin has recently emerged as a key regulator of the reproductive system in women and has been shown to stimulate the secretion of another important hormone.

Research Team

Stephanie Seminara, MD β€” Innovation ...

Stephanie B. Seminara, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for women aged 18-45 with a BMI between 18.5 and 35 who have been diagnosed with PCOS. Participants should have normal blood pressure, not be pregnant or breastfeeding, avoid heavy alcohol use, and not be on hormonal medications unless they can stop them before the study.

Inclusion Criteria

Not breastfeeding
You have been diagnosed with PCOS or show similar symptoms.
Your blood pressure should be within the range of 140/90 or lower.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Review of medical history, physical exam, and screening laboratories

1 day
1 visit (in-person)

Treatment

Participants receive a 24-hour infusion of kisspeptin with up to two IV boluses

24 hours
1 visit (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • GnRH
  • Kisspeptin 112-121
Trial Overview The study aims to understand how kisspeptin affects hormone patterns in those with PCOS by comparing it to GnRH (a natural hormone). It will look at the body's response to kisspeptin and its effect on luteinizing hormone levels.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: kisspeptinExperimental Treatment1 Intervention
IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.

GnRH is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Gonadorelin for:
  • Infertility
  • Precocious puberty
  • Endometriosis
  • Prostate cancer
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Approved in European Union as Gonadorelin for:
  • Infertility
  • Precocious puberty
  • Endometriosis
  • Prostate cancer
  • Breast cancer
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Approved in Canada as Gonadorelin for:
  • Infertility
  • Precocious puberty
  • Endometriosis
  • Prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stephanie B. Seminara, MD

Lead Sponsor

Trials
10
Recruited
840+

Findings from Research

MVT-602, a KISS1R agonist, demonstrated a similar ability to induce luteinizing hormone (LH) release in healthy women compared to native kisspeptin-54, but with a delayed peak and longer duration of action, suggesting enhanced therapeutic potential.
In women with reproductive disorders like polycystic ovary syndrome (PCOS) and hypothalamic amenorrhea (HA), MVT-602 showed effective LH responses, indicating its potential utility in treating various female reproductive health issues.
Kisspeptin receptor agonist has therapeutic potential for female reproductive disorders.Abbara, A., Eng, PC., Phylactou, M., et al.[2022]
In a study involving 28 obese and overweight women with PCOS, 28 normal weight women with PCOS, and 13 obese controls, it was found that higher levels of metastin (kisspeptin) were associated with lower insulin resistance and free androgen levels.
The research suggests that insulin resistance in PCOS may lead to increased androgen production and decreased sex hormone-binding globulin (SHBG) levels, indicating a complex relationship between metabolism and reproductive hormones in women with this condition.
Plasma metastin levels are negatively correlated with insulin resistance and free androgens in women with polycystic ovary syndrome.Panidis, D., Rousso, D., Koliakos, G., et al.[2022]
In a study of subfertile women with PCOS, higher levels of kisspeptin were significantly associated with increased luteinizing hormone (LH) and decreased follicle-stimulating hormone (FSH), indicating a potential hormonal imbalance in these patients.
The findings suggest that elevated kisspeptin levels may contribute to the hyper-stimulation of the hypothalamic-pituitary-gonadal (HPG) axis in women with PCOS, which could play a role in their subfertility.
Kisspeptin Variations in Patients with Polycystic Ovary Syndrome-A Prospective Case Control Study.Akad, M., Socolov, R., Furnică, C., et al.[2022]

References

Kisspeptin receptor agonist has therapeutic potential for female reproductive disorders. [2022]
Plasma metastin levels are negatively correlated with insulin resistance and free androgens in women with polycystic ovary syndrome. [2022]
Kisspeptin Variations in Patients with Polycystic Ovary Syndrome-A Prospective Case Control Study. [2022]
NIH conference. Therapeutic applications of luteinizing-hormone-releasing hormone and its analogs. [2019]
Establishment and clinical application of enzyme immunoassays for determination of luteinizing hormone releasing hormone and metastin. [2011]
Clinical aspects of LHRH analogues in gynaecology: a review. [2013]
Clinical Translational Studies of Kisspeptin and Neurokinin B. [2021]
Gonadotropins and Their Analogs: Current and Potential Clinical Applications. [2022]
Use of luteinizing hormone releasing hormone agonists in polycystic ovary syndrome. [2019]
The Correlation between Hormonal Disturbance in PCOS Women and Serum Level of Kisspeptin. [2022]
Polycystic ovary syndrome (PCOS) and kisspeptin - A Sri Lankan study. [2020]
Kisspeptin and Polycystic Ovary Syndrome. [2023]
13.Korea (South)pubmed.ncbi.nlm.nih.gov
Comprehensive Review on Kisspeptin and Its Role in Reproductive Disorders. [2022]
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