Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

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
menstruation

- 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
administration

- 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
partner

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

- for women, breastfeeding