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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
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 18 and 45 years old.You have been diagnosed with PCOS or show similar symptoms.Your blood pressure should be within the range of 140/90 or lower.You need to have a negative pregnancy test before being given the kisspeptin treatment.Your hemoglobin level is not more than 0.5 g/dL below the normal range for healthy women.You don't drink more than 10 alcoholic drinks per week or use illegal drugs.The study doctor will check if your current use of marijuana might affect your participation in the study.Your body mass index (BMI) is between 18.5 and 35.
Research Study Groups:
This trial has the following groups:- Group 1: kisspeptin, GnRH
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity to enroll in this experiment?
"The requirements for this trial are that patients have polycystic ovary syndrome and be within the age bracket of 18 to 45. A limit of 26 participants is placed on the study."
Answered by AI
Is this research restricted to seniors, or can individuals under 80 participate?
"To be considered for this medical trial, potential participants must fall within the 18-45 age range. Separately, there are 19 clinical trials designed specifically for younger people and 5 studies tailored to those above 65."
Answered by AI
Has the FDA given clearance to kisspeptin and GnRH?
"At Power, we rate kisspeptin and GnRH's safety at 1 because it is only in the first stage of clinical trials. As such, there is just enough data to suggest its potential efficacy and security."
Answered by AI
Is the recruitment process for participants still ongoing?
"Clinicaltrials.gov confirms that this clinical trial is no longer recruiting participants. The initial post went online on July 31st 2023, and the most recent update was posted on the same day. Despite these findings, there are still 106 other trials accepting patients at present."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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