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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00456274
Other study ID # 1999P-003770
Secondary ID
Status Recruiting
Phase N/A
First received April 2, 2007
Last updated July 31, 2014
Start date September 1999
Est. completion date September 2020

Study information

Verified date July 2014
Source Massachusetts General Hospital
Contact Natalie Shaw, MD
Phone 617-726-1895
Email nshaw@partners.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Description:

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Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
Frequent baseline blood sampling
3 ml of blood sampled every 10 minutes for a total of 8-12 hours

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (14)

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Outcome

Type Measure Description Time frame Safety issue
Primary Number of luteinizing hormone (LH) and FAS (free alpha subunit) pulses 8-12 hours No
Secondary Amplitude of LH and FAS pulses 8-12 hours No
Secondary Inter-pulse interval for LH and FAS pulses 8-12 hours No
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