Neuropeptides in Human Reproduction
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/2/2019 |
| Start Date: | January 2014 |
| End Date: | December 2022 |
| Contact: | Isabella McDonald |
| Email: | MGHKisspeptinResearch@partners.org |
| Phone: | 617-726-8484 |
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 GnRH and
kisspeptin, 2 other naturally occurring reproductive hormones.
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 GnRH and
kisspeptin, 2 other naturally occurring reproductive hormones.
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, plates, 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)
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Stephanie B Seminara, MD
Phone: 617-726-5383
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