Primary Ovarian Insufficiency: Phenotype and Optimal Treatment

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Patty Brisben Foundation For Women's Sexual Health
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria for POI patients

The participant must:

1. Be willing to give informed consent/assent

2. Have a diagnosis of POI based on 2 elevated serum FSH levels obtained >1 month apart

3. Be English-speaking

Exclusion Criteria for POI patients

The participant must not:

1. Have other chronic disease known to affect bone health (e.g., cystic fibrosis, celiac disease, etc.)

2. Have an identified secondary cause of ovarian insufficiency

3. Have POI in the setting of Turner syndrome, Fanconi Anemia, galactosemia, or Perrault syndrome (as associated neurological/medical sequelae could confound baseline measures)

4. Have used medications known to affect bone metabolism over previous 3 months (e.g. anticonvulsants, chronic use of glucocorticords, Depo-Provera, oral contraceptive pills)

5. Be currently pregnant (to be confirmed by pregnancy testing)

Inclusion Criteria for Healthy Adolescent Control Participants

The participant must:

1. Be similar in age and race group to the idiopathic POI group

1. 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

2. Race of controls participants will be matched based on race of POI patient participants

2. Have a BMI within 20% of the BMI of the case-matched participant

3. 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

4. Be English-speaking

Exclusion Criteria for Healthy Adolescent Control Participants

The participant must not:

1. Have a chronic disease, known to affect bone metabolism (e.g., cystic fibrosis, celiac disease, sickle cell disease, inflammatory bowel disease etc.)

2. 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.)

3. Have a learning disability or a developmental delay

4. Be currently taking any SSRIs, antipsychotics or have any documented problems with anxiety or depression.

5. Be currently pregnant (as confirmed by pregnancy testing)