Hormone Replacement for Premature Ovarian Insufficiency (HOPE)
Primary Ovarian Insufficiency
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency focused on measuring premature ovarian failure, hormone replacement
Eligibility Criteria
Inclusion Criteria:
- Female patients,
- Between 14-45 years of age
- Post-menarchal
- Presence of uterus
- POI as defined by: change in menstrual function (oligomenorrhea and/or amenorrhea), elevated serum serum follicle stimulating hormone (FSH), low serum estradiol concentrations, or estrogen deficiency symptoms.
Exclusion Criteria:
- Pregnancy or lactation within previous 3 months
- Use of hormonal contraception or replacement within previous 3 months
- Any contraindication to oral contraceptive pills or hormone replacement therapy per the current drug labels. These could include, but are not limited to: history of venous thromboembolism,estrogen-sensitive cancer history, regular cigarette smoking and history of or active liver disease, etc.
- Patients will be screened for pregnancy with a urine HCG test at time of screening
Sites / Locations
- Penn Fertility Care
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Hormone Replacement Therapy
Combined Oral Contraceptives
Patient will be given hormones in the form of: transdermal estradiol patch (Climara) 100 mcg/24 hours weekly, progesterone (Prometrium) 200 mg per day for first 12 calendar days of each month (If patients insurance plan does not cover transdermal estradiol, they will be prescribed oral estradiol 2 mg daily. If patients insurance plan does not cover Prometrium, they will be prescribed medroxyprogesterone (Provera) 10 mg per day for first 12 calendar days of each month).
Patients will be given hormones in the form of: monophasic combined oral contraceptive containing ethinyl estradiol 0.035 mg and norgestimate 0.25 mg, 1 tablet daily (21 days of active pills and 7 days of inactive pills)