Dampening the Reproductive Axis With Continuous Kisspeptin
Purpose
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).
Conditions
- Reproductive Disorder
- PCOS
- Polycystic Ovary Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental kisspeptin |
IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Stephanie B. Seminara, MD
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