Neuropeptides in Human Reproduction

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Hypogonadotropic Hypogonadism

Treatments: Drug: Naloxone; Drug: Kisspeptin 112-121; Drug: GnRH

Study type: Interventional

Funder types: Other

Identifiers

NCT01952782

2013P001543

Details and patient eligibility

About

The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone.

We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH))

• Normal blood pressure (systolic BP <140 mm Hg, diastolic BP <90 mm Hg)

• White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range

• Negative urine drug screen panel

• Hemoglobin:

  1. For healthy men and healthy regularly cycling women: normal
  2. For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women

• Blood urea nitrogen (BUN), creatinine, liver function tests not elevated

• For healthy subjects: Normal reproductive function and history

• For healthy subjects: Body Mass Index (BMI) 18.5-30kg/m2

• For subjects with HH: All medical conditions stable and well controlled

Exclusion criteria

• History of medication reaction requiring emergency medical attention
• Illicit drug use
• Consumption of more than 10 alcoholic drinks per week
• Difficulty with blood draws
• Currently seeking fertility, breastfeeding, or pregnant
• For healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication)
• For subjects with HH: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Naloxone, Kisspeptin, GnRH

Experimental group

Description:

Intravenous (IV) administration of kisspeptin 112-121, GnRH, and naloxone

Treatment:

Drug: GnRH

Drug: Naloxone

Drug: Kisspeptin 112-121