Trial record 14 of 18 for:    "Klinefelter Syndrome"

Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01438073
First received: August 24, 2011
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

The investigators are seeking subjects for a study of the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that stimulates the production of reproductive hormones. Continuous administration of kisspeptin paradoxically suppresses the reproductive endocrine axis temporarily. By administering 24-hour infusions of kisspeptin, the investigators hope to learn more about the role of kisspeptin both in normal physiology and pathological conditions.

The investigators are initially seeking healthy men, healthy women with regular menstrual cycles, and healthy postmenopausal women. In a later part of the study, the investigators will also enroll subjects with reproductive disorders. Study participation involves 2 outpatient visits and one 38-hour hospital admission when subjects will receive kisspeptin and Gonadotropin releasing hormone (GnRH). Individuals interested in learning more may call 617-724-1083.


Condition Intervention Phase
Hypogonadotropic Hypogonadism
Healthy Postmenopausal Women
Primary Gonadal Insufficiency in Men
Hypergonadotropic Hypogonadism in Men
Klinefelter Syndrome
Drug: kisspeptin 112-121
Drug: GnRH
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Luteinizing hormone (LH) level [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Follicle stimulating hormone (FSH) levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • testosterone (males) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • estradiol (females) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Complete blood count (CBC) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Blood urea nitrogen (BUN) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • creatinine [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • liver function studies [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 156
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: kisspeptin, GnRH
24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)
Drug: kisspeptin 112-121
24-h continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg)
Other Name: metastin 45-54
Drug: GnRH
Single intravenous dose of GnRH (2.5-250 ng/kg)
Other Name: gonadotropin-releasing hormone

Detailed Description:

Please contact study staff for a detailed description.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 21-40 years (healthy men and regularly cycling women) OR age 50-60 years (healthy postmenopausal women)
  • history of normal puberty with respect to onset and pace
  • Body mass index (BMI) 18.5-30 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
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438073

Contacts
Contact: Cindy Li, BA 617-724-1083 cli17@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Stephanie B Seminara, MD         
Sub-Investigator: Yee-Ming Chan, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Stephanie B Seminara, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Stephanie B. Seminara, MD, Associate in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01438073     History of Changes
Other Study ID Numbers: 2011-P-001564
Study First Received: August 24, 2011
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Klinefelter Syndrome
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 27, 2014