Status:
COMPLETED
Dampening the Reproductive Axis With Continuous Kisspeptin
Lead Sponsor:
Stephanie B. Seminara, MD
Conditions:
Reproductive Disorder
PCOS
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
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).
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05971849
Start Date
October 6 2023
End Date
April 27 2024
Last Update
November 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114