CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 110 enrolled
Drug / intervention
Physiologic Estrogen/progesterone +1 moredrug
Likely dose
Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the monthAI-extracted
Key inclusion· 2
  • ✓Female adolescents aged 12–18 years with anorexia nervosa and amenorrhea
  • ✓Normal-weight girls aged 12–18 years with no history of eating disorder (control group)
Key exclusion· 6
  • ✕Untreated thyroid disease
  • ✕Premature ovarian failure, diabetes, cancer, or pituitary disease
  • ✕Renal disease or bone fracture within the past six months
  • ✕Prescription medications affecting bone metabolism within three months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00088153
NCT00088153Phase 3Completed
CompareCT.gov

Effects of Anorexia Nervosa on Peak Bone Mass

Massachusetts General Hospital·interventional·Posted Jul 21, 2004·Updated Nov 2, 2021

In Brief

A Phase 3 clinical trial evaluating Physiologic Estrogen/progesterone and Placebo for Anorexia Nervosa. Completed, enrolled 110 participants across 1 site.

Detailed Summary

This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in adolescents. Whether administration of estrogen, a normal hormone present during puberty, can help maintain bone development in girls with anorexia nervosa will be determined.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnorexia Nervosa
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Hospital for Sick Children

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2004
Enrollment StartJul 1, 2003
Primary CompletionFeb 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 21.9 years ago

Interventions

Physiologic Estrogen/progesteronedrug

Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month

Placeboother

Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month