MedTrace Logo

Baselines in Reproductive Disorders

NCT00456274 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2014-08-04

No results posted yet for this study

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

Interventions

PROCEDURE

Frequent baseline blood sampling

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Janet E Hall, M.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-30
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00456274 on ClinicalTrials.gov