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NCT01428193 · ClinicalTrials.gov registry record · NA

Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

A NA study, sponsored by University of Virginia.

Terminated
Registry status
NA
Development phase
4
Enrollment target

NCT01428193: Clinical Trial NA study, sponsored by University of Virginia.

NCT01428193 is a NA study that was terminated before completion, run by University of Virginia. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01428193, a NA study, was terminated before completion, sponsored by University of Virginia.

TERMINATED
Registry status
NA
Development phase
4 participants
Enrollment target

Study Summary

The purpose of this study is to understand the effects of elevated male hormones in adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If the investigators understand the effects of elevated male hormones levels in girls, the investigators may be able to better treat girls with elevated male hormone levels and perhaps even learn how to prevent the development of PCOS. Females with elevated levels of male hormones respond differently to estrace (estradiol) and progesterone than females with normal male hormone levels. The investigators will be giving you estrogen and progesterone to see how you respond after the male hormone has been blocked by a medication called flutamide.

Primary Outcome

The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.

Interventions

  • DRUG Progesterone
  • DRUG Flutamide
  • DRUG estrace

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2006-09
Est. Completion 2017-08
Phase NA
University of Virginia

449 total trials

Why NCT01428193 stopped before completion

NCT01428193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 3 interventions - of which Progesterone is the first listed.

NCT01428193 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01428193 about?

NCT01428193 is a clinical study titled "Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone". The purpose of this study is to understand the effects of elevated male hormones in adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If the investigators understand the effects of elevated male hormones levels in girls, the investigators may be able to better...

What is the current status of trial NCT01428193?

This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2006-09. Estimated completion is 2017-08.

What interventions are being tested in trial NCT01428193?

The interventions under investigation include: Progesterone (DRUG), Flutamide (DRUG), estrace (DRUG).

Who is sponsoring clinical trial NCT01428193?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01428193's enrollment target sits among peer trials

4 1996th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01428193, the US trial registry maintained by the National Library of Medicine. NCT01428193 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.