Dampening the Reproductive Axis With Continuous Kisspeptin

Stephanie B. Seminara, MD

Status and phase: Completed; Phase 1

Conditions: PCOS; Polycystic Ovary Syndrome; Reproductive Disorder

Treatments: Drug: kisspeptin 112-121

Study type: Interventional

Funder types: Other

Identifiers

NCT05971849

2023P001356

Details and patient eligibility

About

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).

Full 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

Enrollment: 8 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

kisspeptin

Experimental group

Description:

IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.

Treatment:

Drug: kisspeptin 112-121