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

Study Summary

This trial looks at how PCOS patients respond to a hormone treatment and their natural hormone levels.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average change in LH pulse amplitude

Average change in LH pulse frequency

Trial Design

1Treatment groups

Experimental Treatment

Group I: kisspeptin, GnRHExperimental Treatment2 Interventions

IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

kisspeptin 112-121

2013

Completed Phase 1

~120

GnRH

2017

Completed Phase 2

~320

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.

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Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor

9 Previous Clinical Trials

1,314 Total Patients Enrolled

Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital

8 Previous Clinical Trials

5,580 Total Patients Enrolled

1 Trials studying Polycystic Ovary Syndrome

496 Patients Enrolled for Polycystic Ovary Syndrome

Media Library

GnRH (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05971849 — Phase 1

Polycystic Ovary Syndrome Research Study Groups: kisspeptin, GnRH

Polycystic Ovary Syndrome Clinical Trial 2023: GnRH Highlights & Side Effects. Trial Name: NCT05971849 — Phase 1

GnRH (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05971849 — Phase 1

~16 spots leftby Jun 2025

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