Kisspeptin for Polycystic Ovary Syndrome
Trial Summary
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.
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
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
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Review of medical history, physical exam, and screening laboratories
Treatment
Participants receive a 24-hour infusion of kisspeptin with up to two IV boluses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- GnRH (Hormone Therapy)
- Kisspeptin 112-121 (Hormone Therapy)
GnRH is already approved in United States, European Union, Canada for the following indications:
- Infertility
- Precocious puberty
- Endometriosis
- Prostate cancer
- Infertility
- Precocious puberty
- Endometriosis
- Prostate cancer
- Breast cancer
- Infertility
- Precocious puberty
- Endometriosis
- Prostate cancer