Primary Ovarian Insufficiency: Phenotype and Optimal Treatment
Primary Ovarian Insufficiency
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency focused on measuring Primary Ovarian Insufficiency, Hormone Replacement Therapy, Estrogen Deficiency
Eligibility Criteria
Inclusion Criteria for POI patients
The participant must:
- Be willing to give informed consent/assent
- Have a diagnosis of POI based on 2 elevated serum FSH levels obtained >1 month apart
- Be English-speaking
Exclusion Criteria for POI patients
The participant must not:
- 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 glucocorticords, Depo-Provera, oral contraceptive pills)
- Be currently pregnant (to be confirmed by pregnancy testing)
Inclusion Criteria for Healthy Adolescent Control Participants
The participant must:
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
- Have a BMI within 20% of the BMI of the case-matched participant
If postmenarchal, will be regularly menstruating (cycles between 21-35 days)
a. if POI participant is <12.5yrs (mean age of menarche) will match with a pre- menarchal control participant
- Be English-speaking
Exclusion Criteria for Healthy Adolescent Control Participants
The participant must not:
- Have a chronic disease, known to affect bone metabolism (e.g., cystic fibrosis, celiac disease, sickle cell disease, inflammatory bowel disease etc.)
- Be receiving medications known to affect bone metabolism over previous three months (e.g. anticonvulsants, chronic use of glucocorticoids, Depo-Provera, oral contraceptive pills, etc.)
- Have a learning disability or a developmental delay
- Be currently taking any SSRIs, antipsychotics or have any documented problems with anxiety or depression.
- Be currently pregnant (as confirmed by pregnancy testing)
Sites / Locations
- Cincinnati Children's Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control Participants
POI Participants
The control group will reflect a comparison group similar to the POI patient group. As bone density, body composition, and cognitive domains continue to mature throughout the teenage years, this comparison group will provide an important metric of normal growth and development.
This group will be participants who have been recently diagnosed with POI. In an open-label fashion, participants with POI will receive Transdermal Estrogen(beginning at a dose of 25 μg/patch applied weekly), with the dose increased at 3, 6 12, and 18 months (to 37.5, 50, 75, and 100 µg/patch).