Status:
COMPLETED
Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hypogonadotropic Hypogonadism
Healthy Postmenopausal Women
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 produc...
Detailed Description
Please contact study staff for a detailed description.
Eligibility Criteria
Inclusion
- A. Healthy Subjects
- All healthy subjects will meet the following criteria:
- normal puberty with respect to onset and pace,
- no difficulty with blood draws,
- no prescription medications for at least 2 months with the exception of asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication,
- 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:
- Healthy Men:
- between 21 and 40 years old,
- normal erectile and ejaculatory function, no history of reproductive disorders,
- testicular volume \>15 ml.
- Healthy women:
- between 21 and 40 years old,
- not breastfeeding or pregnant,
- menstrual cycles between 25 and 35 days in duration with no more than 5 days variability in cycle duration,
- no evidence for androgen excess (hirsutism or acne),
- Healthy postmenopausal women:
- between 48 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:
- all medical conditions stable and well controlled, medications allowed include asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication,
- no 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,
- Additional criteria based on subject population:
- Men and women with hypogonadotropic hypogonadism,
- 18 years or older,
- 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.
- Agonadal men,
- Between 18 and 60 years old.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01438073
Start Date
September 1 2011
End Date
April 1 2016
Last Update
July 11 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114