Kisspeptin Administration in the Adult (NCT00914823) | Clinical Trial Compass
CompletedPhase 1
Kisspeptin Administration in the Adult
United States256 participantsStarted 2009-06-23
Plain-language summary
The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 unde…
What they're measuring
1
Average change in luteinizing hormone (LH) in response to kisspeptin