Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01438073
Recruitment Status : Recruiting
First Posted : September 21, 2011
Last Update Posted : June 20, 2018
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

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 produce other reproductive hormones. However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction. By giving 24-hour infusions of kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way bodies function normally and the role it has in conditions that affect the reproductive system.

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 617-726-8484.

Condition or disease Intervention/treatment 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

Detailed Description:
Please contact study staff for a detailed description.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 411 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
Actual Study Start Date : September 2011
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Luteinizing hormone (LH) level [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Follicle stimulating hormone (FSH) levels [ Time Frame: 6 hours ]
  2. testosterone (males) [ Time Frame: 6 hours ]
  3. estradiol (females) [ Time Frame: 6 hours ]
  4. Complete blood count (CBC) [ Time Frame: 1 month ]
  5. Blood urea nitrogen (BUN) [ Time Frame: 1 month ]
  6. creatinine [ Time Frame: 1 month ]
  7. liver function studies [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age 21-40 years (healthy men and regularly cycling women) OR age 48-60 years (healthy postmenopausal women)
  • history of normal puberty with respect to onset and pace
  • body mass index (BMI) 18.5-35 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 and a history of regular menstrual cycles
  • 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, certain psychotropic medications, levothyroxine for hypothyroidism, albuterol for asthma, statins for dyslipidemia 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438073

Contact: Isabella McDonald 617-726-8484
Contact: Margaret Lippincott, M.D. 617-726-8434

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         
Sub-Investigator: Margaret Lippincott, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Stephanie B Seminara, MD Massachusetts General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephanie B. Seminara, MD, Associate in Medicine, Massachusetts General Hospital Identifier: NCT01438073     History of Changes
Obsolete Identifiers: NCT01862094
Other Study ID Numbers: 2011-P-001564
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Klinefelter Syndrome
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs