Overview

Administration of Kisspeptin to Subjects With Reproductive Disorders

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators are seeking participants for a study of the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occuring hormone in humans that stimulates the production of reproductive hormones. The investigators hypothesize that kisspeptin administration will be a useful tool for characterizing certain reproductive disorders.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Massachusetts General Hospital
Treatments:
Hormones
Criteria
A. Healthy Subjects

All healthy subjects will meet the following criteria:

- normal puberty with respect to onset and pace,

- no chronic diseases,

- no difficulty with blood draws,

- no prescription medications for at least 2 months with the exception of seasonal
allergy medications and hormone replacement therapy,

- no illicit drug use or excessive alcohol consumption (< 10 drinks/week),

- no history of a medication reaction requiring emergency medical care,

- normal physical exam and laboratory studies within protocol reference ranges.

Additional criteria based on subject population:

1. Healthy Men:

- between 21 and 40 years old,

- normal erectile and ejaculatory function, no history of reproductive disorders,

- testicular volume >15 ml.

2. Healthy women:

- between 21 and 40 years old,

- not breastfeeding or pregnant,

- menstrual cycles between 25 and 35 days in duration, at least 11 periods/year,
with no more than 5 days variability in cycle duration,

- no evidence for androgen excess (hirsutism or acne),

- at screening, negative hCG pregnancy test,

- negative screening for Factor V Leiden for those who might receive estradiol
treatment as a part of this study.

3. Healthy postmenopausal women:

- between 50 and 60 years old,

- no menstrual periods within the last year,

- previous history of menstrual cycles between 25 and 35 days in duration, with no
more than 5 days variability in cycle duration,

- if applicable, able to undergo washout from hormone therapy,

- no evidence for androgen excess (hirsutism or acne),

- negative screening for Factor V Leiden for those who might receive estradiol
treatment as a part of this study.

B. Subjects with Reproductive Disorders

All subjects with reproductive disorders will meet the following criteria:

- 18 years or older,

- all medical conditions stable and well controlled,

- no prescription medications known to affect reproductive endocrine function for at
least 2 months except for medications used to treat the subject's reproductive
condition,

- no history of a medication reaction requiring emergency medical care,

- no illicit drug use or excessive alcohol consumption (<10 drinks/week),

- for women, not breastfeeding or pregnant,

- if applicable, able to undergo appropriate washout from hormone therapy,

- normal physical exam and laboratory studies within protocol reference ranges,

- for women, at time of screening negative hCG pregnancy test.

Additional criteria based on subject population:

1. Men and women with hypogonadotropic hypogonadism,

- Confirmed diagnosis by low sex steroids in the setting of low or inappropriately
normal gonadotropins,

- If needed, additional labs and imaging tests may be performed.

2. Women with Polycystic Ovarian Syndrome (PCOS)

- Confirmed diagnosis of PCOS,

- If needed, additional labs and imaging tests may be performed.

3. Men and women with hyperprolactinemia

- confirmed diagnosis of elevated levels of prolactin measured via blood test,

- no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a
macroprolactinoma confirmed on MRI imaging will be excluded,

- willing to complete a dopamine agonist washout.