Dampening the Reproductive Axis With Continuous Kisspeptin

Sponsor

Stephanie B. Seminara, MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05971849

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

Condition or Disease	Intervention/Treatment	Phase
Reproductive Disorder PCOS Polycystic Ovary Syndrome	Drug: kisspeptin 112-121 Drug: GnRH	Phase 1

Detailed Description

Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.

Delivery of Interventions:

Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
On the day of the study, the subjects will have an intravenous (IV) line placed and
Undergo up to q10 min blood sampling x 36 hours
Receive an infusion of kisspeptin x 24 hours
Receive up to two kisspeptin IV boluses
Receive up to one gonadotropin-releasing hormone (GnRH) IV bolus

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Dampening the Reproductive Axis With Continuous Kisspeptin

Anticipated Study Start Date :

Jul 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: kisspeptin, GnRH IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus.	Drug: kisspeptin 112-121 IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin Other Names: metastin 45-54 Drug: GnRH Up to one IV bolus of GnRH Other Names: gonadotropin-releasing hormone

Arm

Intervention/Treatment

Experimental: kisspeptin, GnRH

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

Drug: kisspeptin 112-121

IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin

Other Names:

metastin 45-54

Drug: GnRH

Up to one IV bolus of GnRH

Other Names:

gonadotropin-releasing hormone

Outcome Measures

Primary Outcome Measures

Average change in LH pulse frequency [6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion]
Average change in LH pulse frequency before and during kisspeptin infusion
Average change in LH pulse amplitude [6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion]
Average change in LH pulse amplitude before and during kisspeptin infusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Ages 18-45 years
A history of clinical diagnosis of PCOS or equivalent clinical features
BMI >18.5 and <35 kg/m2
Normal blood pressure (systolic BP < 140 mm Hg, diastolic > 90 mm Hg)
Laboratory studies:
Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration
Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for healthy women
Not using hormonal medication or willing to complete an appropriate washout for that particular medication and its method of administration
No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration
No history of a medication reaction that required emergency medical care
No excessive alcohol consumption (>10 drinks/week) and/or ongoing use of illicit drugs

• Any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation

Not pregnant or trying to become pregnant
Not breastfeeding
No history of bilateral oophorectomy (both ovaries removed)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Stephanie B. Seminara, MD

Investigators

Principal Investigator: Stephanie B Seminara, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05971849

Other Study ID Numbers:

2023P001356

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General Hospital

reproductive disorders

kisspeptin

PCOS

GnRH

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Hormones

Study Results

No Results Posted as of Aug 2, 2023