NCT05971849CompletedPhase 1
Dampening the Reproductive Axis With Continuous Kisspeptin
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 17 Jul 2023
- Start date
- 6 Oct 2023
- Primary completion date
- 27 Apr 2024
- Lead sponsor
- Stephanie B. Seminara, MD
- NCT number
- NCT05971849
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From 6 Oct 2023 to the primary completion date, 27 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.