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.