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Trial Title:
Dampening the Reproductive Axis With Continuous Kisspeptin
NCT ID:
NCT05971849
Condition:
Reproductive Disorder
PCOS
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Conditions: Keywords:
reproductive disorders
kisspeptin
PCOS
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
kisspeptin 112-121
Description:
IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
Arm group label:
kisspeptin
Other name:
metastin 45-54
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).
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
Criteria for eligibility:
Criteria:
- 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 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
617-643-2308
Email:
MGHKisspeptinResearch@partners.org
Start date:
October 6, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Stephanie B. Seminara, MD
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05971849
