CompletedPhase 3

Primary Ovarian Insufficiency: Phenotype and Optimal Treatment

United States19 participantsStarted 2018-11-01

Plain-language summary

This pilot study will observe the progression of newly diagnosed POI patients physical and psychology outcomes after initiating standard of care HRT treatment in comparison to healthy female control participants' physical and psychology health over 24 months.

Who can participate

Age range11 Years – 18 Years

SexFEMALE

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Inclusion criteria

✓. Be willing to give informed consent/assent
✓. Have a diagnosis of POI based on 2 elevated serum follicle stimulating hormone (FSH) levels obtained \>1 month apart.
✓. Be English-speaking

Exclusion criteria

✕. Have other chronic disease known to affect bone health (e.g., cystic fibrosis, celiac disease, etc.)
✕. Have an identified secondary cause of ovarian insufficiency
✕. Have POI in the setting of Turner syndrome, Fanconi Anemia, galactosemia, or Perrault syndrome (as associated neurological/medical sequelae could confound baseline measures)
✕. Have used medications known to affect bone metabolism over previous 3 months (e.g. anticonvulsants, chronic use of glucocorticoids, Depo-Provera, oral contraceptive pills)
✕. Be currently pregnant (to be confirmed by pregnancy testing)
✕. Be similar in age and race group to the idiopathic POI group
✕. Control participants age must be within one year of age from the POI participant at the time of enrollment. Age may be within one year older or one year younger
✕. Race of controls participants will be matched based on race of POI patient participants

What they're measuring

Change in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) of the Lumbar Spine

Timeframe: Change in bone mineral density and body composition from baseline to 24 months

Trial details

NCT IDNCT03568708

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-05

Results submitted2024-01-26

View on ClinicalTrials.gov More Primary Ovarian Insufficiency trials