Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT00456274

Conditions

Amenorrhea

Hypogonadotropic Hypogonadism

Kallmann's Syndrome

Eligibility Criteria

Sex: Female

Age: 16 - 45

Healthy Volunteers: Not accepted

Interventions

Frequent baseline blood sampling

Study Details

Brief summary:

The purpose of the study is to explore the way in which gonadotropins (pituitary hormones) are released into the body. The knowledge acquired in this study will be used for the diagnosis and treatment of reproductive endocrine disorders.

We seek to investigate the baseline characteristics of the GnRH-induced gonadotropin pulsations of patients with the following diagnoses:

  • Hypothalamic Amenorrhea (HA)
  • Idiopathic hypogonadotropic hypogonadism (IHH)
  • Polycystic ovarian disease (PCOD)
  • Acquired hypogonadotropic hypogonadism (AHH)
  • Premature Ovarian Failure (POF)

\*\*WE ARE CURRENTLY RECRUITING ONLY SUBJECTS WITH A DIAGNOSIS OF IHH.\*\*

This has been an extremely productive and pivotal protocol in the studies of female reproductive physiology and pathophysiology and continues to be critical for defining the neuroendocrine abnormalities in patients with reproductive disorders. In some cases, it is also helpful in the planning of subsequent therapy if so desired.

It is important to note that minors have been included in this protocol, as many patients are extremely anxious to know more about their neuroendocrine disorder. With minors who would like to know if their disorder is correctable, this protocol may be followed up with administration of pulsatile gonadotropin-releasing hormone (GnRH).

Conditions

Amenorrhea

Hypogonadotropic Hypogonadism

Kallmann's Syndrome

Study ID

NCT00456274

Start date

Sep, 1999

Status verified date

Jul, 2014

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Healthy women between the ages of 16-45 years
  • Negative pregnancy test
  • On no gonadal steroid preparations for at least 3 months, with the exception of the idiopathic hypogonadotropic hypogonadism (IHH) group, they should be off gonadal steroid for at least 4 weeks

The following test will be performed if they had not been done in the last 2 months

  • Normal blood count
  • Normal thyroid function test

Exclusion Criteria:

  • Hemoglobin levels less than 11 gm/dL
  • Positive pregnancy test
  • Abnormal thyroid function
  • Abnormal MRI (IHH)

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 1

Interventions

Frequent baseline blood sampling

3 ml of blood sampled every 10 minutes for a total of 8-12 hours

Primary outcome measure

  • Number of luteinizing hormone (LH) and FAS (free alpha subunit) pulses [ Time Frame: 8-12 hours ]

Central Contacts and Locations

Central contacts

Natalie Shaw, MD

617-726-1895nshaw@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 4, 2014

Last verified

Jul, 2014

Keywords

  • Hypothalamic Amenorrhea
  • Idiopathic hypogonadotropic hypogonadism
  • Acquired hypogonadotropic hypogonadism
  • Kallmann's Syndrome
  • Amenorrhea
  • Gonadotropin Releasing Hormone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2014-08-04.