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NCT00013546 · ClinicalTrials.gov registry record · Phase 2

Hormone Replacement Therapy to Treat Turner Syndrome

A Phase 2 study of Osteoporosis and Turner's Syndrome, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
Phase 2
Development phase
92
Enrollment target
1
Study location

NCT00013546: Completed Phase 2 study of Osteoporosis and Turner's Syndrome, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT00013546 is a Phase 2 study of Osteoporosis and Turner's Syndrome that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 92 participants, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00013546, a Phase 2 study of Osteoporosis and Turner's Syndrome, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
Phase 2
Development phase
92 participants
Enrollment target
1
Study location

Study Summary

This study will evaluate the effects of hormone replacement therapy on patients with Turner syndrome (TS)-a genetic disorder in females in which part or all of one X chromosome is missing. Most girls and women with TS have underdeveloped ovaries-the female reproductive organs that produce the female sex hormones estrogen and progesterone, and smaller amounts of the male sex hormone, testosterone. These hormones affect muscle and bone strength, sex drive, energy, and an overall sense of well being. Estrogen may also play a role in memory and mood and have a protective effect against heart disease. Women with TS have a much higher risk of developing osteoporosis (loss of bone density), high blood pressure, high cholesterol and diabetes than women without this disorder. Girls and women with Turner syndrome between the ages of 14 and 50 years may be eligible for this 2-year study. Three months before beginning treatment, all patients will wear an estrogen patch and take a progesterone tablet daily for 10 days each month. They will then be randomly assigned to one of two treatment groups to compare the effects of estrogen alone with estrogen plus testosterone on bone strength, muscle and fat mass and psychosocial well being. Both groups will wear an estrogen patch and take oral progesterone. One group will also wear a testosterone patch while the other group will wear a placebo patch (a patch that does not contain any testosterone). Neither study participants nor the doctors will know who is getting the testosterone until the study is complete. Patients will undergo the following procedures before beginning treatment and at 6, 12 and 24 months after starting treatment: * Physical examination. * DEXA scans (dual energy X-ray absorptiometry) to measure body composition and bone thickness. Low radiation X-rays scan the whole body to measure fat, muscle and bone mineral content.. * Magnetic resonance imaging (MRI) scan of the abdomen to measure the amount of fat around the

Conditions Studied

Osteoporosis Turner's Syndrome

Interventions

  • DRUG TMTDS

Study Locations (1)

Maryland

  • National Institute of Child Health and Human Development (NICHD) - Bethesda

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2001-03
Est. Completion 2002-12
Phase Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

305 total trials

What the finished NCT00013546 record still lists

NCT00013546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,545-participant average among 84 other Osteoporosis trials with a reported enrollment target (94% lower).

The record links to 2 conditions, with Osteoporosis appearing as the primary indexed condition, and to 1 intervention - of which TMTDS is the first listed.

NCT00013546 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00013546 about?

NCT00013546 is a clinical study titled "Hormone Replacement Therapy to Treat Turner Syndrome". This study will evaluate the effects of hormone replacement therapy on patients with Turner syndrome (TS)-a genetic disorder in females in which part or all of one X chromosome is missing. Most girls and women with TS have underdeveloped ovaries-the female reproductive organs that produce the female...

What is the current status of trial NCT00013546?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2001-03. Estimated completion is 2002-12.

What conditions does trial NCT00013546 study?

This clinical trial studies the following conditions: Osteoporosis, Turner's Syndrome.

What interventions are being tested in trial NCT00013546?

The interventions under investigation include: TMTDS (DRUG).

Who is sponsoring clinical trial NCT00013546?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00013546 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Osteoporosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00013546's enrollment target sits among peer trials

92 41st of 84 higher than 44 of 84 other Osteoporosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoporosis 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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Related registry views

Source: ClinicalTrials.gov NCT00013546, the US trial registry maintained by the National Library of Medicine. NCT00013546 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.