Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Conditions:Other Indications, Endocrine
Therapuetic Areas:Endocrinology, Other
Age Range:21 - 60
Start Date:September 2011
End Date:September 2023
Contact:Isabella McDonald

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The investigators are looking for subjects to complete a study on the role of kisspeptin in
the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the
body to produce other reproductive hormones. However, giving someone a continued amount of
kisspeptin over a period of time can have the opposite effect and tell the body to, for a
short time, stop making hormones needed for reproduction. By giving 24-hour infusions of
kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way
bodies function normally and the role it has in conditions that affect the reproductive

Please contact study staff for a detailed description.

Inclusion Criteria:

- age 21-40 years (healthy men and regularly cycling women) OR age 48-60 years (healthy
postmenopausal women)

- history of normal puberty with respect to onset and pace

- body mass index (BMI) 18.5-35 kg/m2; -systolic blood pressure <140 mm Hg, diastolic
blood pressure <90 mm Hg

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

- hemoglobin:

1. For men and postmenopausal women: normal

2. For cycling women not in follicular phase: within normal reference range

3. For cycling women in follicular phase: no lower than 1 gm/dL below the lower
limit of the reference range, as they may have slightly lower levels due to

- blood urea nitrogen (BUN), creatinine, liver function tests not elevated

- normal luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone
(men), estradiol (women)

- for cycling women, regular menstrual cycles 25-35 days in duration

- for postmenopausal women, no menstrual periods within the last year and a history of
regular menstrual cycles

- for all women, negative serum human chorionic gonadotropin (hCG) pregnancy test at the
time of screening and negative urine hCG pregnancy test at the time of drug

- for men, normal erectile and ejaculatory function by report, and no history of
reproductive disorders (e.g., cryptorchidism)

- for men, testicular volume 15 mL or greater by Prader orchidometer

Exclusion Criteria:

- use of prescription medications in prior 2 months (with the exception of seasonal
allergy medications, certain psychotropic medications, levothyroxine for
hypothyroidism, albuterol for asthma, statins for dyslipidemia for all or hormone
replacement therapy for postmenopausal women)

- illicit drug use

- consumption of more than 10 alcoholic drinks per week

- history of anaphylactic reactions

- history of chronic disease

- difficulty with blood draws

- for cycling women, use of hormonal therapy in prior 2 months

- for women, lack of access of non-hormonal contraception if sexually active with a male

- for women, evidence of androgen excess (e.g., hirsutism or acne)

- for women, breastfeeding
We found this trial at
185 Cambridge Street
Boston, Massachusetts 02114
Principal Investigator: Stephanie B Seminara, MD
Boston, MA
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