What side effects are associated with this type of intervention?

Common treatments for Polycystic Ovary Syndrome (PCOS) that stimulate the release of gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) include clomiphene citrate, aromatase inhibitors like letrozole, and metformin. Clomiphene citrate can cause side effects such as hot flashes, ovarian enlargement, and multiple pregnancies. Aromatase inhibitors like letrozole may lead to fatigue, dizziness, and joint pain. Metformin, often used to address insulin resistance in PCOS, can cause gastrointestinal issues like nausea, diarrhea, and abdominal discomfort. GnRH analogs, which are sometimes used, can result in menopausal symptoms such as hot flashes and decreased bone density. Gonadotropins, used for ovulation induction, carry risks of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancies.

What prior FDA approvals exist?

For the treatment of Polycystic Ovary Syndrome (PCOS), the FDA has approved several drugs that focus on ovulation induction. Clomiphene citrate, a selective estrogen receptor modulator, is widely used to induce ovulation by increasing gonadotropin release. Letrozole, an aromatase inhibitor, is also used for ovulation induction and has shown higher live birth rates compared to clomiphene. Metformin, although not primarily an ovulation induction agent, is used to improve menstrual regularity and metabolic parameters in PCOS patients. These treatments, while not directly stimulating GnRH like kisspeptin, aim to regulate hormonal imbalances and promote ovulation.

What other types of research exist?

Promising alternatives to Kisspeptin for PCOS treatment include: 1) Letrozole, an aromatase inhibitor, which has shown better ovulation rates compared to clomiphene citrate. 2) Metformin, which improves insulin sensitivity and can help restore normal menstrual cycles. 3) Gonadotropin-releasing hormone (GnRH) analogs, which can regulate LH and FSH levels. 4) Elagolix, an oral GnRH antagonist, which has been effective in managing endometriosis-associated pain and may have potential in PCOS management.

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Hormone Therapy

Kisspeptin for Polycystic Ovary Syndrome

Phase 1

Recruiting

Led By Stephanie B Seminara, MD

Research Sponsored by Stephanie B. Seminara, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to hormonal changes such as mood swings, acne, weight changes, or menstrual irregularities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average change in LH pulse amplitude

Average change in LH pulse frequency

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: kisspeptinExperimental Treatment1 Intervention

IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

kisspeptin 112-121

2013

Completed Phase 1

~420

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Polycystic Ovary Syndrome (PCOS) target hormonal imbalances and insulin resistance. Kisspeptin stimulates the release of gonadotropin-releasing hormone (GnRH), which in turn increases luteinizing hormone (LH) secretion, aiding in ovulation. Clomiphene citrate and letrozole also promote ovulation by enhancing gonadotropin release. Insulin-sensitizing agents like metformin improve insulin resistance and lower androgen levels. Weight loss is recommended to restore ovulation and improve metabolic health. These treatments are essential as they address the root causes of PCOS, improving symptoms and fertility.

Kisspeptin and neurokinin B interactions in modulating gonadotropin secretion in women with polycystic ovary syndrome.